TACROLIMUS ( DrugBank: Tacrolimus )


34 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
6パーキンソン病1
11重症筋無力症8
13多発性硬化症/視神経脊髄炎1
36表皮水疱症2
46悪性関節リウマチ17
49全身性エリテマトーデス5
50皮膚筋炎/多発性筋炎8
51全身性強皮症5
53シェーグレン症候群4
56ベーチェット病1
60再生不良性貧血17
61自己免疫性溶血性貧血1
62発作性夜間ヘモグロビン尿症2
65原発性免疫不全症候群7
66IgA腎症2
85特発性間質性肺炎1
95自己免疫性肝炎2
96クローン病4
97潰瘍性大腸炎17
113筋ジストロフィー1
151ラスムッセン脳炎1
158結節性硬化症1
164眼皮膚白皮症1
222一次性ネフローゼ症候群35
224紫斑病性腎炎3
226間質性膀胱炎(ハンナ型)1
227オスラー病2
228閉塞性細気管支炎1
283後天性赤芽球癆3
284ダイアモンド・ブラックファン貧血1
285ファンコニ貧血1
286遺伝性鉄芽球性貧血1
299嚢胞性線維症3

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT01884571
(ClinicalTrials.gov)
October 201319/6/2013Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Basiliximab;Drug: Methylprednisolone;Drug: Prednisone;Drug: Tacrolimus;Drug: Mycophenolate mofetilEmory UniversityALS AssociationCompleted18 YearsN/AAll31Phase 2United States

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1JPRN-JMA-IIA00385
01/08/201812/09/2018Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's DiseaseKyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease Parkinson's diseaseIntervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value..Kyoto University HospitalNULLCompleted>=50 YEARS<70 YEARSBOTH7Phase 3Japan

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1ChiCTR2200057193
2022-03-022022-03-02Study on the dominant population of tacrolimus in the treatment of myasthenia gravisStudy on the dominant population of tacrolimus in the treatment of myasthenia gravis myasthenia gravisExperimental group:Tacrolimus;Shijiazhuang People's HospitalNULLPending190BothExperimental group:100;Phase 4China
2NCT04768465
(ClinicalTrials.gov)
January 1, 202121/2/2021Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia GravisEffectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world StudyMyasthenia GravisDrug: Pyridostigmine, Prednisone, Tacrolimus;Drug: Pyridostigmine, TacrolimusDa, Yuwei, M.D.NULLRecruiting18 YearsN/AAll160China
3JPRN-UMIN000015019
2014/09/0202/09/2014Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIGInitial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG - Combined therapy for tacrolimus and IVIG Myasthenia gravisTacrolimus and IVIGKansai medical universityNULLRecruitingNot applicableNot applicableMale and Female20Not applicableJapan
4JPRN-UMIN000007679
2012/04/0109/04/2012Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patientsRandomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients - Efficacy and safety of tacrolimus in ocular myasthenia gravis Myasthenia gravisAdministration of tacrolimus 3 mg/day
Administration of prednisolone 5 mg/day
anticholinesterases
Department of Neurology, Chiba University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
5JPRN-UMIN000007671
2012/04/0109/04/2012Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patientsRandomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients - Steroid combined with tacrolimus for late- or elderly-onset patients of myasthenia gravis (STEP-MG) Myasthenia gravisAdministration of prednisolone 35 mg/day with tacrolimus 3mg a day
Administration of prednisolone 50 mg/day
Department of Neurology, Chiba University Graduate School of MedicineNULLRecruiting50years-oldNot applicableMale and Female40Not applicableJapan
6NCT01325571
(ClinicalTrials.gov)
March 201116/3/2011A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia GravisA Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid TherapyMyasthenia GravisDrug: Tacrolimus capsule;Drug: PlaceboAstellas Pharma IncAstellas Pharma China, Inc.Completed18 Years70 YearsBoth83Phase 3China
7NCT00309088
(ClinicalTrials.gov)
April 200629/3/2006FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) PatientsFK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis PatientsMyasthenia GravisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNULLCompleted16 Years64 YearsBoth80Phase 3Japan
8NCT00309101
(ClinicalTrials.gov)
February 200629/3/2006An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsFK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsMyasthenia GravisDrug: tacrolimusAstellas Pharma IncNULLCompleted16 Years64 YearsBoth11Phase 3Japan

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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gender
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size
PhaseCountries
1NCT00298662
(ClinicalTrials.gov)
February 20032/3/2006Combination Therapy of Betaseron-Prograf in Multiple SclerosisA Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying AgentsMultiple SclerosisDrug: Interferon beta-1b and TacrolimusClinique de sclérose en plaques et neuromusculaire de l'OutaouaisNULLActive, not recruiting18 Years55 YearsBoth30Phase 2Canada

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
1NCT02582775
(ClinicalTrials.gov)
March 201616/10/2015MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCsMT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell InfusionsEpidermolysis BullosaProcedure: Bone marrow infusion;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Biological: Donor mesenchymal stem cell infusions;Drug: Busulfan;Drug: Thymoglobulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body IrradiationMasonic Cancer Center, University of MinnesotaNULLActive, not recruitingN/A25 YearsAll17Phase 2United States
2NCT00881556
(ClinicalTrials.gov)
August 20, 200914/4/2009Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)A Pilot Study of Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (ALLOSCT) In Children With Recessive Dystrophic Epidermolysis Bullosa (RDEB)Epidermolysis BullosaDrug: Palifermin;Drug: Fludarabine;Drug: Busulfan;Drug: Lorazepam;Drug: Alemtuzumab;Drug: TacrolimusColumbia UniversityNULLTerminatedN/A21 YearsAll3Early Phase 1United States

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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size
PhaseCountries
1NCT03737708
(ClinicalTrials.gov)
February 13, 20198/11/2018A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical TrialRheumatoid Arthritis (RA)Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abataceptAstellas Pharma Korea, Inc.NULLCompleted19 Years75 YearsAll21Phase 4Korea, Republic of
2NCT02373202
(ClinicalTrials.gov)
February 201512/2/2015A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: MizoribineSanofiRegeneron PharmaceuticalsCompleted20 YearsN/AAll91Phase 3Japan
3NCT02837978
(ClinicalTrials.gov)
January 201513/7/2016The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term TreatmentProspective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in ChinaArthritis, RheumatoidDrug: Tacrolimus;Drug: MTXQiang ShuNULLRecruiting18 Years80 YearsAll150Phase 4China
4JPRN-UMIN000013546
2014/06/0131/03/2014The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusThe effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNULLPending16years-old80years-oldMale and Female20Not applicableJapan
5JPRN-UMIN000012690
2013/12/2827/12/2013Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost TreatmentStudy of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment - STARR-SMARRT Rheumatoid Arthritistocilizumab+tacrolimus+Bucillamine
tocilizumab
National hospital organization Chiba east national hospital Clinical Research CenterNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
6JPRN-UMIN000010126
2013/02/2526/02/2013Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung diseaseEfficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD Interstitial lung disease related to rheumatoid arthritisIn cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.
Department of Lifetime Clinical Immunology, Tokyo Medical and Dental UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female34Not applicableJapan
7NCT01746680
(ClinicalTrials.gov)
August 20124/12/2012Efficacy and Safety Study of Tacrobell to Treat Rheumatoid ArthritisPhase IV STudy of Tacrobell in Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Tacrolimus with MethotrexateChong Kun Dang PharmaceuticalNULLCompleted20 YearsN/ABoth111Phase 4Korea, Republic of
8NCT01870908
(ClinicalTrials.gov)
August 20124/6/2013Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis PatientsDrug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical SettingsRheumatoid ArthritisDrug: tacrolimus;Drug: biological agentsAstellas Pharma IncNULLCompletedN/AN/ABoth664N/AJapan
9JPRN-UMIN000008572
2012/07/3131/07/2012The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patientsThe Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients - K-NET study: The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.
Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks.
Department of Rheumatology and infectious disease, Kitasato university school of medicine1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinicComplete: follow-up complete20years-old70years-oldMale and Female80Not applicableJapan
10JPRN-UMIN000006702
2012/02/0111/11/2011A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid ArthritisA parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis - An intensive treatment strategy in patients with active early RA rheumatoid arthritisIntensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Tokyo Medical and Dental UniversityDepartment of PharmacovigilanceComplete: follow-up continuing20years-old70years-oldMale and Female290Not applicableJapan
11JPRN-UMIN000007205
2012/02/0102/02/2012The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritisThe efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis - The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis Rheumatoid arthritis1) Tacrolimus
Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained.
The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on.
However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.
Juntendo UniversityNULLPending65years-oldNot applicableMale and Female30Not selectedJapan
12NCT01511003
(ClinicalTrials.gov)
December 5, 20114/1/2012A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDsRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed20 Years75 YearsAll128Phase 4Korea, Republic of
13NCT01224041
(ClinicalTrials.gov)
August 200918/10/2010Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateClinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 StudyRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years75 YearsBoth78Phase 4Korea, Republic of
14NCT01224418
(ClinicalTrials.gov)
May 200814/10/2010A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to MethotrexateClinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 StudyRheumatoid ArthritisDrug: TacrolimusAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years75 YearsBoth50Phase 4Korea, Republic of
15JPRN-UMIN000000512
2006/10/0103/11/2006Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexateEfficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate - Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project) Rheumatoid ArthritisIf the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.
Rheumatosurgery, Osaka City University Medical SchoolNULLComplete: follow-up completeNot applicableNot applicableMale and Female30Not applicableJapan
16NCT00319917
(ClinicalTrials.gov)
April 200627/4/2006A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA PatientsFK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA PatientsRheumatoid ArthritisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNULLCompleted20 Years64 YearsBoth123Phase 4Japan
17NCT00036153
(ClinicalTrials.gov)
March 20028/5/2002Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid ArthritisA Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to MethotrexateRheumatoid ArthritisDrug: Tacrolimus (Prograf®);Drug: MethotrexateAstellas Pharma IncAstellas Pharma US, Inc.Completed18 YearsN/ABoth210Phase 3United States;Canada

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
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PhaseCountries
1NCT05666336
(ClinicalTrials.gov)
December 31, 20228/12/2022Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE PatientsProteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: TacrolimusFen LiNULLNot yet recruiting18 Years75 YearsAll30Phase 4NULL
2NCT02080195
(ClinicalTrials.gov)
September 13, 201628/2/2014Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLELupus Erythematosus;Graft-versus-host DiseaseDrug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplantSidney Kimmel Comprehensive Cancer Center at Johns HopkinsMaryland Stem Cell Research FundTerminated18 Years75 YearsAll1Phase 1/Phase 2United States
3JPRN-UMIN000025328
2015/12/0525/12/2016A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus NephritisA Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis systemic lupus erythematosusTacrolimus
Mycophenolate Mofetil
The University of Hong KongNULLRecruiting18years-old75years-oldMale and Female200Not selectedJapan,Asia(except Japan)
4JPRN-UMIN000004182
2010/10/0130/09/2010efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosusefficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus - FK for SLE Flare systemic lupus erythematosusAdministration of TacrolimusDepartment of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-old80years-oldMale and Female30Not applicableJapan
5NCT00125307
(ClinicalTrials.gov)
January 200429/7/2005Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisTacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisLupus Nephritis;Lupus Erythematosus, SystemicDrug: tacrolimusChinese University of Hong KongNULLCompleted18 YearsN/ABoth20Phase 4Hong Kong;China

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
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agemin
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PhaseCountries
1ChiCTR1900028143
2020-01-012019-12-13Effect of Tacrolimus on dermatomyositis/polymyositisA Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis dermatomyositis/polymyositisControl group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide;Department of Rheumatology and Immunology, Tianjin Medical University General HospitalNULLPending1870BothControl group:20;Treatment group:20;Control group:20;Phase 4China
2JPRN-UMIN000032193
2018/04/1113/04/2018Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trialEfficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung diseasePatients without poor prognostic factors:
combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.

For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months.
Second Division, Department of Internal Medicine, Hamamatsu University School of MedicineNULLRecruiting20years-old80years-oldMale and Female40Not selectedJapan
3JPRN-UMIN000032022
2018/04/0101/04/2018Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trialEfficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung diseaseArm 1: corticosteroid (prednisolone) monotherapy for 24 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.)
Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).
Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.)
Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.
Hamamatsu University School of MedicineNULLRecruiting20years-old80years-oldMale and Female66Not selectedJapan
4JPRN-UMIN000015469
2014/10/2018/10/2014Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung diseaseComparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung diseasearm1: tacrolimus and predonisolon therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.
arm2: cyclosporine and predonisolone therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml.
Second Division, Department of Internal medicine, Hamamatsu University School of MedicineNULLComplete: follow-up complete18years-old75years-oldMale and Female50Not selectedJapan
5JPRN-UMIN000013546
2014/06/0131/03/2014The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusThe effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNULLPending16years-old80years-oldMale and Female20Not applicableJapan
6NCT02159651
(ClinicalTrials.gov)
April 1, 20146/6/2014A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial PneumoniaSpecified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/DermatomyositisInterstitial Pneumonia Associated With Polymyositis/DermatomyositisDrug: tacrolimusAstellas Pharma IncNULLCompletedN/AN/AAll179Japan
7JPRN-JMA-IIA00012
20/07/200705/07/2007Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant TacrolimusAn open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controls Interstitial pneumonitis associated with polymyositis/dermatomyositisIntervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg..IMPPACT study central officeHokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and DentistryCompleted>=16 YEARS<75 YEARSBOTH20Phase 2-3Japan
8NCT00504348
(ClinicalTrials.gov)
July 200719/7/2007Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant TacrolimusAn Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical ControlsInterstitial Pneumonitis;Polymyositis;DermatomyositisDrug: TacrolimusTokyo Medical and Dental UniversityJapan Medical Association;Astellas Pharma IncCompleted16 Years74 YearsAll25Phase 2/Phase 3Japan

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ITMCTR2100004289
2021-03-012021-01-19Observation of curative effection of Milli Fire Needle in treating Localized SclerodermaFeasibility and Safety of Milli Fire Needle in Localized Scleroderma Treatment Localized Sclerodermacontrol group:0.1% tacrolimus oinment;treatment group:Milli Fire Needle+0.1% tacrolimus oinment;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLRecruiting1865Bothcontrol group:45;treatment group:45;China
2ChiCTR2100042327
2021-03-012021-01-19Observation of curative effection of Milli Fire Needle in treating Localized SclerodermaFeasibility and Safety of Milli Fire Needle in Localized Scleroderma Treatment Localized Sclerodermatreatment group:Milli Fire Needle+0.1% tacrolimus oinment;control group:0.1% tacrolimus oinment;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLRecruiting1865Bothtreatment group:45;control group:45;China
3NCT02680717
(ClinicalTrials.gov)
March 20169/2/2016Comparative Effectiveness Trial in the Treatment of Pediatric Plaque MorpheaComparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque MorpheaSclerodermaDrug: Clobetasol;Drug: Calcipotriene;Drug: TacrolimusMedical College of WisconsinMayo Clinic;Seattle Children's Hospital;University of TorontoWithdrawn2 Years18 YearsAll0Phase 1NULL
4NCT01047072
(ClinicalTrials.gov)
January 201011/1/2010Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic SclerosisPhase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic SclerodermaDrug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationFred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumNational Cancer Institute (NCI)Withdrawn18 Years65 YearsBoth0Phase 2United States
5NCT00622895
(ClinicalTrials.gov)
September 1, 200622/2/2008Allogeneic Hematopoietic Cell Transplantation for Severe Systemic SclerosisAllogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic Scleroderma;Severe Systemic SclerosisDrug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsyFred Hutchinson Cancer Research CenterNational Institute of Allergy and Infectious Diseases (NIAID)CompletedN/A70 YearsAll3Phase 1/Phase 2United States

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03865888
(ClinicalTrials.gov)
October 30, 201816/12/2018Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren SyndromeEvaluation of the Effect of Topical Application of Tacrolimus 0.03% (FK506) Eye Drops Versus Cyclosporine 0.05% Eye Drops in Treatment of Dry Eye in Secondary Sjogren SyndromeDry Eye;Sjogren SyndromeDrug: Cyclosporins;Drug: TacrolimusPavly MoawdNULLCompleted20 Years70 YearsAll60Phase 3Egypt
2ChiCTR-IPR-17013772
2018-01-012017-12-08A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry EyeA Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye Sjogren's Syndrome Dry Eyegroup of tacrolimus eye drops:tacrolimus eye drops;group of flurometholone eye drops:flurometholone eye drops;The Eye Hospital of Wenzhou Medical UniversityNULLPendingBothgroup of tacrolimus eye drops:30;group of flurometholone eye drops:30;China
3ChiCTR-OIB-16007789
2016-01-182015-12-300.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation Sjogren's syndromeTacrolimus therapy group:0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days;Eye Institute of Xiamen UniversityNULLRecruiting1870BothTacrolimus therapy group:30;4 (Phase 4 study)China
4NCT01850979
(ClinicalTrials.gov)
February 20101/5/2013Treatment of Dry Eye Using 0.03% Tacrolimus Eye DropsTreatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized StudySjogren Syndrome;Dry Eye SyndromeDrug: Tacrolimus;Drug: Olive OilUniversity of Sao Paulo General HospitalNULLCompleted40 Years60 YearsBoth24Phase 4Brazil

56. ベーチェット病


臨床試験数 : 81 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05032248
(ClinicalTrials.gov)
April 1, 201927/8/2021Uses of Tacrolimus in Behcet DiseaseUses of Tacrolimus in Treatment of Oral Ulcers in Behcet DiseaseOral Ulcer;Behcet SyndromeDrug: Tacrolimus ointmentAssiut UniversityNULLCompleted18 Years70 YearsAll40N/AEgypt

60. 再生不良性貧血


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05031897
(ClinicalTrials.gov)
October 25, 202131/8/2021Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell TransplantA 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity ConditioningAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Chronic Lymphocytic Leukemia;Chronic Myelomonocytic Leukemia;Essential Thrombocythemia;Hematopoietic and Lymphoid Cell Neoplasm;Hodgkin Lymphoma;Myelodysplastic Syndromes;Myelofibrosis;Myeloid Leukemia;Myeloid Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Polycythemia Vera;Small Lymphocytic LymphomaProcedure: Hematopoietic Cell Transplantation;Drug: Mycophenolate Mofetil;Drug: Tacrolimus;Drug: Cyclophosphamide;Radiation: Total-Body Irradiation;Procedure: Donor Lymphocyte Infusion;Drug: Fludarabine;Drug: MelphalanThomas Jefferson UniversityNULLRecruiting18 YearsN/AAll67Phase 2United States
2NCT04403321
(ClinicalTrials.gov)
July 1, 202021/5/2020Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia PatientsEfficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia PatientsAplastic Anemia;Drug EffectDrug: Tacrolimus;Drug: Placebo (for Tacrolimus)Peking Union Medical College HospitalNULLCompleted14 Years85 YearsAll114Phase 2China
3NCT02918292
(ClinicalTrials.gov)
July 3, 201727/9/2016Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)Severe Aplastic AnemiaDrug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSFMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramCompletedN/A75 YearsAll32Phase 2United States
4NCT02960646
(ClinicalTrials.gov)
January 18, 20178/11/2016Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesPhase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical TransplantationAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Aplastic Anemia;Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Therapy-Related Myelodysplastic SyndromeDrug: Cyclophosphamide;Biological: Filgrastim;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Biological: Rituximab;Drug: Tacrolimus;Radiation: Total-Body IrradiationM.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed18 Years65 YearsAll11Phase 1United States
5NCT02833805
(ClinicalTrials.gov)
September 201612/7/2016NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic AnemiaSevere Aplastic Anemia;Aplastic Anemia;Bone Marrow Failure;ImmunosuppressionDrug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total body irradiation;Drug: Tacrolimus;Drug: Mycophenolate mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/AN/AAll21Phase 2United States
6NCT02566304
(ClinicalTrials.gov)
November 13, 201530/9/2015Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAcute Myeloid Leukemia;Acute Myeloid Leukemia in Remission;Aplastic Anemia;Chronic Myelomonocytic Leukemia;Hodgkin Lymphoma;Indolent Non-Hodgkin Lymphoma;Malignant Neoplasm;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Refractory Anemia;Refractory Anemia With Excess Blasts;Refractory Anemia With Ring Sideroblasts;Refractory Cytopenia With Multilineage Dysplasia;Refractory Cytopenia With Multilineage Dysplasia and Ring SideroblastsDrug: Fludarabine;Radiation: Total-Body Irradiation;Biological: T Cell-Depleted Donor Lymphocyte Infusion;Drug: Cyclophosphamide;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate mofetil;Other: Laboratory Biomarker AnalysisSidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLRecruiting18 YearsN/AAll35Phase 2United States
7NCT02224872
(ClinicalTrials.gov)
August 201418/8/2014Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure SyndromesSevere Aplastic Anemia;Bone Marrow Failure SyndromesProcedure: Bone marrow transplant;Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: TBI;Drug: Mesna;Drug: Tacrolimus;Drug: Mycophenolic acid mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A73 YearsAll18Phase 2United States
8NCT01760655
(ClinicalTrials.gov)
December 24, 20122/1/2013Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic MalignanciesA Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic MalignanciesAcute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM;Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214;Aplastic Anemia;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Follicular Lymphoma;Hodgkin Lymphoma;Myelodysplastic Syndrome;Myelofibrosis;Myeloid Leukemia;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Adult Acute Myeloid Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Refractory Acute Myeloid Leukemia;Secondary Acute Myeloid Leukemia;Therapy-Related Acute Myeloid LeukemiaDrug: Fludarabine phosphate;Drug: Busulfan;Radiation: Total-Body Irradiation;Biological: Therapeutic Allogeneic Lymphocytes;Drug: Cyclophosphamide;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Other: Laboratory Biomarker AnalysisSidney Kimmel Cancer Center at Thomas Jefferson UniversityNational Cancer Institute (NCI)CompletedN/AN/AAll62Phase 2United States
9NCT01659606
(ClinicalTrials.gov)
July 20126/8/2012Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis CongenitaRadiation- and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita / Telomere DiseaseDyskeratosis Congenita;Hoyeraal Hreidarsson Syndrome;Revesz Syndrome;Aplastic AnemiaBiological: alemtuzumab;Drug: Fludarabine;Drug: Cyclosporins;Drug: Mycophenolate mofetil;Drug: TacrolimusBoston Children's HospitalDana-Farber Cancer Institute;Children's Hospital Medical Center, Cincinnati;Children's Hospital Los Angeles;Fred Hutch/University of Washington/Seattle Children's Cancer Consortium;Baylor College of Medicine;Children's Hospital of Philadelphia;University of Wisconsin, Madison;Karolinska University Hospital;Hackensack Meridian Health;Duke University;Oslo University Hospital;Children's Mercy Hospital Kansas City;Mayo Clinic;University of Chicago;Massachusetts General HospitalActive, not recruiting30 Days65 YearsAll40Phase 2United States;Norway;Sweden
10NCT01529827
(ClinicalTrials.gov)
February 28, 20126/2/2012Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body IrradiationAccelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationRoswell Park Cancer InstituteNULLCompleted3 Years75 YearsAll94Phase 2United States
11NCT01384513
(ClinicalTrials.gov)
August 4, 201127/6/2011A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological MalignanciesA Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aplastic Anemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Essential Thrombocythemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Juvenile Myelomonocytic Leukemia;Mastocytosis;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Anemia;Refractory Anemia With Ringed Sideroblasts;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Myelodysplastic Syndromes;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenström Macroglobulinemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q)Drug: Fludarabine;Drug: Busulfan;Radiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide (CY);Drug: Tacrolimus;Drug: Mycophenolate mofetil;Device: Allogeneic hematopoietic stem cell transplantation;Procedure: Peripheral blood stem cell transplantation (PBSCT)Sidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLCompleted18 YearsN/AAll40Phase 2United States
12NCT01350245
(ClinicalTrials.gov)
July 20104/5/2011Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative DonorA Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related DonorsAcute Myeloid Leukemia;Myelodysplastic Syndromes;Biphenotypic Leukemia;Acute Lymphocytic Leukemia;Chronic Myeloid Leukemia;Chronic Lymphocytic Leukemia;Plasma Cell Neoplasms;Lymphoma;Hodgkin's Disease;Aplastic AnemiaRadiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus;Device: Hematopoietic stem cell transplantation (HSCT)Sidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLCompleted18 YearsN/AAll28Phase 2United States
13EUCTR2006-006577-25-SE
(EUCTR)
25/07/200711/06/2007A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantationA prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders
MedDRA version: 9.1;Level: LLT;Classification code 10018799;Term: GVHD
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: SIROLIMUS
Other descriptive name: Rapamycin
Trade Name: Prograf
Product Name: Prograf
INN or Proposed INN: TACROLIMUS
Other descriptive name: FK-506
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Other descriptive name: CsA
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Finland;Sweden
14NCT00358657
(ClinicalTrials.gov)
May 24, 200628/7/2006Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited DisordersHLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting CyclophosphamideImmunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;DonorProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingN/A55 YearsAll14Phase 2United States
15NCT00295997
(ClinicalTrials.gov)
May 200523/2/2006Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic AnemiaNon-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic AnemiaChronic Myeloproliferative Disorders;Kidney Cancer;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: graft-versus-tumor induction therapy;Biological: therapeutic allogeneic lymphocytes;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methotrexate;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationUniversity of California, San FranciscoNational Cancer Institute (NCI)Active, not recruitingN/A74 YearsBoth35N/AUnited States
16NCT00516152
(ClinicalTrials.gov)
November 200213/8/2007Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCTPhase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell TransplantationChronic Myeloid Leukemia;Acute Myelogenous Leukemia;Myelodysplasia;Acute Lymphocytic Leukemia;Severe Aplastic Anemia;Non-Hodgkin's Lymphoma;Lymphoproliferative Disease;Multiple Myeloma;Advanced Myeloproliferative DiseaseDrug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSFUniversity of California, San FranciscoNULLCompleted15 Years61 YearsBoth36Phase 2United States
17NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03918265
(ClinicalTrials.gov)
May 4, 201916/4/2019Tacrolimus Treatment for Refractory Autoimmune CytopeniaTacrolimus Treatment for Refractory Autoimmune CytopeniaAutoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans SyndromeDrug: TacrolimusPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll80Phase 4China

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04965597
(ClinicalTrials.gov)
April 19, 202221/6/2021Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure DiseasesBone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond SyndromeDrug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life AssessmentFred Hutchinson Cancer CenterBlood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI)Recruiting1 Year49 YearsAll40Phase 2United States
2NCT01529827
(ClinicalTrials.gov)
February 28, 20126/2/2012Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body IrradiationAccelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationRoswell Park Cancer InstituteNULLCompleted3 Years75 YearsAll94Phase 2United States

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04965597
(ClinicalTrials.gov)
April 19, 202221/6/2021Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure DiseasesBone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond SyndromeDrug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life AssessmentFred Hutchinson Cancer CenterBlood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI)Recruiting1 Year49 YearsAll40Phase 2United States
2NCT04339777
(ClinicalTrials.gov)
September 22, 20208/4/2020Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityA Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityLymphoproliferative Disorders;Autoimmune Lymphoproliferative;Immune System Diseases;Common Variable Immunodeficiency;Primary T-cell Immunodeficiency DisordersDrug: Busulfan test dose;Drug: Fludarabine;Drug: Busulfan;Drug: Alemtuzumab;Radiation: Total body Irradiation;Procedure: Allogeneic HSCT;Drug: Tacrolimus (Tacro);Drug: Mycophenolate mofetil (MMF);Drug: Cyclophosphamide (Cytoxan)National Cancer Institute (NCI)NULLRecruiting4 Years69 YearsAll66Phase 2United States
3NCT01659606
(ClinicalTrials.gov)
July 20126/8/2012Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis CongenitaRadiation- and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita / Telomere DiseaseDyskeratosis Congenita;Hoyeraal Hreidarsson Syndrome;Revesz Syndrome;Aplastic AnemiaBiological: alemtuzumab;Drug: Fludarabine;Drug: Cyclosporins;Drug: Mycophenolate mofetil;Drug: TacrolimusBoston Children's HospitalDana-Farber Cancer Institute;Children's Hospital Medical Center, Cincinnati;Children's Hospital Los Angeles;Fred Hutch/University of Washington/Seattle Children's Cancer Consortium;Baylor College of Medicine;Children's Hospital of Philadelphia;University of Wisconsin, Madison;Karolinska University Hospital;Hackensack Meridian Health;Duke University;Oslo University Hospital;Children's Mercy Hospital Kansas City;Mayo Clinic;University of Chicago;Massachusetts General HospitalActive, not recruiting30 Days65 YearsAll40Phase 2United States;Norway;Sweden
4NCT01529827
(ClinicalTrials.gov)
February 28, 20126/2/2012Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body IrradiationAccelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationRoswell Park Cancer InstituteNULLCompleted3 Years75 YearsAll94Phase 2United States
5NCT01220531
(ClinicalTrials.gov)
November 8, 201022/9/2010Thymus Transplantation Safety-EfficacySafety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836Complete DiGeorge Anomaly;DiGeorge Syndrome;DiGeorge Anomaly;Complete DiGeorge SyndromeBiological: Cultured Thymus Tissue;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Mycophenolate mofetilM. Louise MarkertNational Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Enzyvant Therapeutics GmbHAvailableN/AN/AAllUnited States
6NCT00358657
(ClinicalTrials.gov)
May 24, 200628/7/2006Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited DisordersHLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting CyclophosphamideImmunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;DonorProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingN/A55 YearsAll14Phase 2United States
7NCT00579527
(ClinicalTrials.gov)
December 19, 200520/12/2007Phase I/II Thymus Transplantation With Immunosuppression #950Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950DiGeorge Anomaly;Complete DiGeorge Anomaly;Complete Atypical DiGeorge Anomaly;Complete DiGeorge Syndrome;Complete Atypical DiGeorge SyndromeBiological: Cultured Thymus Tissue for Implantation (CTTI);Other: Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Daclizumab;Drug: Mycophenolate mofetilEnzyvant Therapeutics GmBHNational Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)CompletedN/AN/AAll14Phase 1/Phase 2United States

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-IPR-15006760
2015-08-072015-07-16Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical studyEfficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study IgA nephropathyTacrolimus Group :Tacrolimus;Glucocorticoids Group :Glucocorticoids;Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLPending1865BothTacrolimus Group :90;Glucocorticoids Group :90;China
2NCT01224028
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsDouble-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA NephropathyIgA NephropathyDrug: Tacrolimus;Drug: PlaceboAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years70 YearsBoth40Phase 2Korea, Republic of

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1900027121
2019-10-282019-11-01The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trialThe efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial nonspecific interstitial pneumonia (NSIP)Group-1:Mycophenolate mofetil dispersible tablets 2 g /d; Steroid 0.75 mg/kg/d;Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d;Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d;Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.;Peking Union Medical College HospitalNULLRecruiting1875BothGroup-1:30;Group-2:30;Group-3:30;Control group:30;Phase 4China

95. 自己免疫性肝炎


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000030743
2019/03/3115/01/2018Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot StudyEfficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study - Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Autoimmune HepatitisTacrolimusHiroshima University HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not selectedJapan
2NCT00608894
(ClinicalTrials.gov)
December 200723/1/2008LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune HepatitisA Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune HepatitisAutoimmune HepatitisDrug: LCP-Tacro (tacrolimus);Drug: AzathioprineVeloxis PharmaceuticalsNULLTerminated18 YearsN/AAll13Phase 2United States;Canada

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04154735
(ClinicalTrials.gov)
November 20198/3/2019Autologous Transplant Targeted Against Crohn'sAutologous Hematopoietic Stem Cell Transplant for Crohn's DiseaseCrohn's DiseaseDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: TacrolimusNorthwestern UniversityNULLWithdrawn18 Years49 YearsAll0Phase 2United States
2NCT01570348
(ClinicalTrials.gov)
July 17, 20122/4/2012Crohn's Allogeneic Transplant StudyAllogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 StudyCrohn DiseaseProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Institutes of Health (NIH)Terminated18 Years60 YearsAll2Phase 2United States
3NCT01233570
(ClinicalTrials.gov)
September 20102/11/2010Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's DiseaseTopical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's DiseaseCrohn DiseaseDrug: TacrolimusUniversity of AberdeenNULLCompleted12 YearsN/ABoth20Phase 2United Kingdom
4JPRN-UMIN000002796
2009/11/0125/11/2009Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. - Clinical trial of tacrolimus for patients with Crohn's disease Crohn's diseaseWe randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks.
For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml).
placebo control
Department of Gastroenterology and Hepatology, Kyoto UniversityNULLRecruiting16years-old65years-oldMale and Female50Phase 2Japan

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000030988
2018/02/0101/02/2018Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapyOpen-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study) Ulcerative ColitisInduce azathioprine and continue maintenance therapy by azathioprine
Induce adalimumab and continue maintenance therapy by adalimumab
Sakura Medical Center, Toho universityNULLPending15years-oldNot applicableMale and Female53Not applicableJapan
2NCT02954159
(ClinicalTrials.gov)
May 18, 201714/10/2016Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UCInduction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Tacrolimus;Drug: Vedolizumab;Other: PlaceboMedical College of WisconsinTakedaTerminated18 Years65 YearsAll4Phase 3United States
3JPRN-UMIN000024936
2016/11/3022/11/2016Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitisEfficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis - Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis Ulcerative colitispatients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.Keio University Gastroenterology and HepatologyNULLRecruiting16years-old150years-oldMale and Female30Not selectedJapan
4JPRN-UMIN000015912
2014/12/1515/12/2014Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimusEfficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus - Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus ulcerative colitisTacrolimus will be decreased gradually three months after it was administered.
Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually.
Osaka Medical CollegeNULLRecruiting16years-old70years-oldMale and Female50Not applicableJapan
5JPRN-UMIN000013546
2014/06/0131/03/2014The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusThe effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNULLPending16years-old80years-oldMale and Female20Not applicableJapan
6JPRN-UMIN000013694
2014/05/1311/04/2014Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPsIndividualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs ulcerative colitisdetermine CYP3A5 SNP status
increase the initial dosage of tacrolimus
Kitasato University Kitasato Institute HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female30Not selectedJapan
7JPRN-UMIN000013716
2014/04/1515/04/2014A study of infliximab administration method for tacrolimus-resistant active ulcerative colitisA study of infliximab administration method for tacrolimus-resistant active ulcerative colitis - A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis ulcerative colitisAfter administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg.
Infliximab monotherapy
Yokohama City University Medical CenterNULLComplete: follow-up complete16years-oldNot applicableMale and Female40Phase 2Japan
8JPRN-UMIN000004201
2013/12/0214/09/2010The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosisThe evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis - Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]: HOOP1 (TCL-UC)-3 [MHP] The patients with moderate to severe active refractory ulcerative colitisGroup of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,
Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,
Osaka City University, Graduate School of Medicine,Department of GastroenterologyNULLComplete: follow-up complete16years-old65years-oldMale and Female50Not selectedJapan
9JPRN-UMIN000010776
2013/06/0101/06/2013An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitisAn open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis - Tacrolimus versus cyclosporine treatment for severe UC Ulcerative colitistacrolimus (Prograf)
cyclosporine (Sandimmune)
Chiba University HospitalNULLRecruiting16years-old65years-oldMale and Female40Not selectedJapan
10JPRN-UMIN000010612
2013/05/0101/05/2013A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitisA comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis - A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis Ulcerative colitisTacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female130Phase 4Japan
11NCT01418131
(ClinicalTrials.gov)
October 201215/8/2011Rectal Tacrolimus in the Treatment of Resistant Ulcerative ProctitisA Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative ProctitisUlcerative ColitisDrug: Rectal tacrolimus;Drug: PlaceboThe University of Western AustraliaRoyal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health ServiceCompleted18 YearsN/ABoth21Phase 4Australia
12JPRN-UMIN000005824
2011/07/0121/06/2011Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitisExamination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis - Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis ulcerative colitisTacrolimus (12weeks)Juntendo UniversityNULLRecruiting16years-old65years-oldMale and Female20Not applicableJapan
13JPRN-UMIN000005033
2011/03/0101/03/2011Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitisOpen-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis - Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis ulcerative colitisPatients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks))
Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week.
Saitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete12years-old75years-oldMale and Female50Not applicableJapan
14JPRN-UMIN000003952
2010/07/0126/07/2010A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitisA multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis - Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis ulcerative colitisFasting condition group: Tacrolimus ingestion 1 hour before meal
Fed condition group: Tacrolimus ingestion immediately following consumption of meal
Department of lower gastroenterology, Hyogo College of MedicineOsaka Medical CollegeOsaka City UniversityComplete: follow-up complete16years-oldNot applicableMale and Female40Phase 4Japan
15JPRN-UMIN000003785
2010/07/0101/07/2010Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. - A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis. Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female80Phase 3Japan
16NCT00347048
(ClinicalTrials.gov)
September 200630/6/2006Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis PatientsTacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis PatientsUlcerative ColitisDrug: tacrolimus;Drug: PlaceboAstellas Pharma IncNULLCompleted16 Years64 YearsBoth62Phase 3Japan
17NCT00643071
(ClinicalTrials.gov)
September 200620/3/2008Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis PatientsTacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 StudyUlcerative ColitisDrug: TacrolimusAstellas Pharma IncNULLCompleted16 Years64 YearsBoth32Phase 3Japan

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000176-33-IT
(EUCTR)
14/02/201123/02/2011Cell Therapy Of Duchenne Muscular Dystrophy by intra-arterial delivery of HLA-identical allogeneic mesoangioblasts - NDCell Therapy Of Duchenne Muscular Dystrophy by intra-arterial delivery of HLA-identical allogeneic mesoangioblasts - ND Duchenne Muscolar Dystrophy
MedDRA version: 9.1;Level: PT;Classification code 10013801
INN or Proposed INN: Tacrolimus
Product Name: hMABs
Other descriptive name: HLA-identical allogeneic mesoangioblasts
Product Name: hMABs
Other descriptive name: HLA-identical allogeneic mesoangioblasts
Product Name: hMABs
Other descriptive name: HLA-identical allogeneic mesoangioblasts
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
Italy

151. ラスムッセン脳炎


臨床試験数 : 1 薬物数 : 2 - (DrugBank : 1) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 33
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00545493
(ClinicalTrials.gov)
November 200216/10/2007Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen EncephalitisEfficacy of Tacrolimus and i.v.-Immunoglobulins in Rasmussen Encephalitis With Start of Treatment in the Acute Disease Stage. Prospective, Randomised, Open Parallel Group StudyRasmussen EncephalitisDrug: Tacrolimus;Drug: i.v. immunoglobulinsUniversity Hospital, BonnOctapharma;Astellas Pharma GmbHActive, not recruitingN/AN/ABoth16Phase 2/Phase 3Germany

158. 結節性硬化症


臨床試験数 : 112 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000002844
2009/09/0103/12/2009Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complexDevelopment of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex - Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex tuberous sclerosis complexApplication of 0.2% Rapamycin ointment (ointment base is 0.03% tacrolimus ointment) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin ointment (ointment base is white petrolatum) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Application of 0.2% Rapamycin gel (base is carboxyvinyl polymer) on skin lesion of one side of the face twice a day for 12 weeks.
Application of gel base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Department of DermatologyGraduate School of Medicine, Osaka UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female21Phase 2,3Japan

164. 眼皮膚白皮症


臨床試験数 : 15 薬物数 : 54 - (DrugBank : 34) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00514982
(ClinicalTrials.gov)
August 7, 20079/8/2007Medical Treatment of Colitis in Patients With Hermansky-Pudlak SyndromeAn Observational Study of the Immunopathogenesis of and Response to Step-Up Inflammatory Bowel Disease Therapy for Hermansky-Pudlak Syndrome-Associated ColitisHermanski-Pudlak Syndrome;Colitis;Cytokines;Lymphocytes;Drug EvaluationDrug: Mesalamine;Drug: Infliximab;Drug: Corticosteroids;Drug: 6-Mercaptopurine;Drug: Tacrolimus;Drug: AdalimumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 YearsN/AAll0Phase 2United States

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05667896
(ClinicalTrials.gov)
June 20237/12/2022Prognostic Model of GC/TAC in the Treatment of MNDevelopment and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus TacrolimusIdiopathic Membranous NephropathyDrug: glucocorticoid + tacrolimusQianfoshan HospitalNULLNot yet recruiting18 Years75 YearsAll50NULL
2NCT05667922
(ClinicalTrials.gov)
June 20237/12/2022Prognostic Model of TAC in the Treatment of MNDevelopment and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With TacrolimusIdiopathic Membranous NephropathyDrug: TacrolimusQianfoshan HospitalNULLNot yet recruiting18 Years75 YearsAll50NULL
3NCT05707377
(ClinicalTrials.gov)
April 202323/1/2023A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous NephropathyA Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous NephropathyPrimary Membranous NephropathyDrug: Zanubrutinib;Drug: TacrolimusBeiGeneNULLNot yet recruiting18 Years75 YearsAll282Phase 2/Phase 3NULL
4NCT05532111
(ClinicalTrials.gov)
September 1, 20221/9/2022Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical TrialEfficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical TrialEfficacy and SafetyDrug: Rituximab combined with tacrolimus induction + rituximab maintenance;Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance;Drug: Glucocorticoid combined with cyclophosphamide induction + maintenanceRenJi HospitalNULLNot yet recruiting18 Years75 YearsAll60N/ANULL
5ChiCTR2200056304
2022-04-292022-02-03Efficacy and safety of Tripterygium Hypoglaucum Root Tablet combined with Tacrolimus Therapy in primary membranous nephropathy with moderate risk: A double-blind, randomised, controlled trialEfficacy and safety of Tripterygium Hypoglaucum Root Tablet combined with Tacrolimus Therapy in primary membranous nephropathy with moderate risk: A double-blind, randomised, controlled trial primary membranous nephropathy with moderate riskcontrol group:tacrolimus combined with placebo;Experimental group:tacrolimus combined with Colquhounia Root Tablets;The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLPending4575Bothcontrol group:60;Experimental group:60;Phase 4China
6ChiCTR2200058661
2022-04-012022-04-13Clinical assessment of tacrolimus in treating patients with membranous nephropathy: A protocol for systematic review and meta-analysisClinical assessment of tacrolimus in treating patients with membranous nephropathy: A protocol for systematic review and meta-analysis Membranous nephropathyExperimental group:Tacrolimus;Control group:Other treatment;People’s Hospital of SongziNULLPending1870BothExperimental group:30;Control group:30;N/AChina
7ChiCTR2100048518
2021-10-312021-07-09A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathyA prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathylow-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No;The Second Affiliated Hospital of Xi'an Jiaotong UniversityNULLPending1870Bothlow-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100;China
8ChiCTR2100050205
2021-09-012021-08-22Prediction of therapeutic effect and prognosis of different treatment schemes for idiopathic membranous nephropathy by intestinal floraPrediction of therapeutic effect and prognosis of different treatment schemes for idiopathic membranous nephropathy by intestinal flora Idiopathic membranous nephropathycontrol group:Nil;experimental group 1:Symptomatic treatment;experimental group 2:Hormone+Tacrolimus;experimental group 3:Hormone+Cyclophosphamide;experimental group 4:Hormone+Mycophenolate mofetil ester;experimental group 5:Rituximab;The First Affiliated Hospital of Shandong First Medical University&Shandong Provincial Qianfoshan HospitalNULLPending1880Bothcontrol group:30;experimental group 1:30;experimental group 2:30;experimental group 3:30;experimental group 4:30;experimental group 5:30;N/AChina
9NCT04629248
(ClinicalTrials.gov)
June 25, 202127/10/2020A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous NephropathyA Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous NephropathyPrimary Membranous NephropathyDrug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineHoffmann-La RocheNULLRecruiting18 Years75 YearsAll140Phase 3United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru
10EUCTR2020-003233-38-PL
(EUCTR)
13/04/202124/02/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: RO5072759
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China
11EUCTR2020-003233-38-IT
(EUCTR)
06/04/202104/06/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: [RO5072759]
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China
12ChiCTR2000032422
2020-09-012020-04-27The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world studyThe efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study Idiopathic membranous nephropathyexperimental group:Tacrolimus;control group:conservative treatment;Shenzhen Second People's HospitalNULLPendingBothexperimental group:24;control group:24;Phase 4Chiina
13ChiCTR2000033766
2020-07-012020-06-11Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimusDiagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus Membranous nephropathy1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus;The First Affiliated Hospital of Bengbu Medical CollegeNULLPending1770Both1:30;2:30;Phase 4China
14ChiCTR2000032523
2020-06-012020-05-01Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial.Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial membranous nephropathyexperimental group:rituximab;control group:tacrolimus;Xinqiao HospitalNULLPending1880Bothexperimental group:40;control group:40;Phase 4China
15ChiCTR2000031003
2020-03-252020-03-20Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimenStudy and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen Idiopathic focal segmental glomerulosclerosisTacrolimus group:Low dose of tacrolimus combined with hormone;hormone group:Use hormones;Southwest Hospital, the First Affiliated Hospital of Army Medical UniversityNULLRecruitingBothTacrolimus group:19;hormone group:19;Phase 4China
16ChiCTR1900022943
2019-05-032019-05-04Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic SyndromePopulation Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome Nephrotic SyndromeCase Series:Tacrolimus;Children's Hospital, Zhejiang University School of MedicineNULLRecruitingBothCase Series:100;Phase 4China
17NCT03864250
(ClinicalTrials.gov)
November 26, 20184/3/2019Tacrolimus Monotherapy for Idiopathic Membranous NephropathyTacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical TrialTacrolimus;Idiopathic Membranous Nephropathy;Clinical TrialDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll124N/AChina
18NCT03549663
(ClinicalTrials.gov)
July 4, 201810/5/2018Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll108N/AChina
19ChiCTR1800016140
2018-07-012018-05-14Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open studyA randomized controlled trial for the treatment of primary membranous nephropathy primary membranous nephropathyTacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks;Sichuan Provincial People's HospitalNULLPending1865BothTacrolimus group:45;Cyclophosphamide group:45;China
20ChiCTR1800014719
2018-02-012018-01-31A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosisA retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis idiopathic focal segmental glomerulosclerosistacrolimus group:nothing;prednisone group:nothing;the First Affiliated Hospital of Third Military Medical UniversityNULLRecruitingBothtacrolimus group:24;prednisone group:17;China
21NCT02921789
(ClinicalTrials.gov)
May 22, 201730/9/2016Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsA Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsKidney Transplantation;Primary Focal Segmental Glomerulosclerosis (FSGS)Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: PrednisoneAstellas Pharma Global Development, Inc.Kyowa Kirin Co., Ltd.Completed18 YearsN/AAll67Phase 2United States;Canada
22ChiCTR-IPR-16008344
2016-04-192016-04-22A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathyA study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy idiopathic membranous nephropathyA:cyclophosphamide ;B:tacrolimus;Baoji Central HospitalNULLRecruitingBothA:30;B:30;China
23EUCTR2013-000226-55-NL
(EUCTR)
04/03/201524/06/2014SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHYEuropean Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN Primary membranous nephropathy
MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Tacrolimus
Product Name: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Other descriptive name: TACROLIMUS
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE ACETATE
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Fundacion Renal Iñigo Alvarez ToledoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
175Spain;Netherlands
24NCT01955187
(ClinicalTrials.gov)
January 201419/9/2013Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous NephropathyEuropean Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)MEMBRANOUS NEPHROPATHYDrug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDEHospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, AachenCompleted18 YearsN/AAll86Phase 3Spain
25NCT01451489
(ClinicalTrials.gov)
October 13, 20115/8/2011The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental GlomerulosclerosisA Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental GlomerulosclerosisFSGSDrug: FK506;Drug: CyclophosphamideNanjing University School of MedicineNULLTerminated14 Years65 YearsAll70N/AChina
26ChiCTR-TRC-11001454
2011-08-012011-08-08Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trialTacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial minimal change disease in adults;ICD10:N04.001Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape;Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLCompletedBothGroup A:60;Group B:60;China
27NCT01162005
(ClinicalTrials.gov)
July 201012/7/2010Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenTherapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenNephrotic SyndromeDrug: TacrolimusSeoul National University HospitalChong Kun Dang PharmaceuticalCompletedN/A18 YearsAll77Phase 4Korea, Republic of
28NCT01161459
(ClinicalTrials.gov)
June 201012/7/2010Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus SteroidResearch Institute of Nephrology, Jinling HospitalIdiopathic Membranous NephropathyDrug: Tripterygium wilfordii;Drug: FK506Zhi-Hong Liu, M.D.NULLCompleted18 Years65 YearsBoth100N/AChina
29EUCTR2007-005410-39-ES
(EUCTR)
11/06/200808/04/2008Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTACEstudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto.
MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy
Trade Name: Advagraf 0,5mg
INN or Proposed INN: tacrolimus
Trade Name: Genoxal
INN or Proposed INN: ciclofosfamida
Trade Name: Dacortín 2,5mg
INN or Proposed INN: prednisona
Trade Name: Advagraf 1mg
INN or Proposed INN: tacrolimus
Trade Name: Advagraf 5mg
INN or Proposed INN: tacrolimus
Trade Name: Dacortín 5mg
INN or Proposed INN: prednisona
Trade Name: Dacortín 30mg
INN or Proposed INN: prednisona
Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Spain
30ChiCTR-TRC-10001024
2008-01-012010-09-14Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosisTacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis primary focal segmental glomerulosclerosisgroup A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;Shanghai Jiaotong University Affiliated Ruijin HospitalNULLCompleted1875Bothgroup A:30;group B:30;China
31NCT00302523
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Membranous NephropathyTacrolimus Treatment of Patients With IdiopathicIdiopathic Membranous NephropathyDrug: TacrolimusNanjing University School of MedicineNULLCompleted18 Years60 YearsBoth16N/AChina
32NCT00302536
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Focal Segmental GlomerulosclerosisTacrolimus Treatment of Patients With Idiopathic Focal SegmentalFocal GlomerulosclerosisDrug: TacrolimusNanjing University School of MedicineNULLWithdrawn15 Years50 YearsBoth0N/AChina
33NCT00362531
(ClinicalTrials.gov)
November 20049/8/2006Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromePhase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromeIdiopathic Membranous Nephropathy;Nephrotic SyndromeDrug: tacrolimus combined with prednisonePeking UniversityNULLCompleted18 Years70 YearsBothPhase 2/Phase 3NULL
34ChiCTR-TRC-09000539
2004-03-012009-09-30Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapyClinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy Nephrotic DiseaseS:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months;Second Hospital of Jilin UniversityNULLCompleted1669BothS:10;L:10;China
35EUCTR2015-001039-18-Outside-EU/EEA
(EUCTR)
03/07/2015Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndromeOpen-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Astellas Pharma Korea, Inc.NULLNAFemale: yes
Male: yes
152Korea, Republic of

224. 紫斑病性腎炎


臨床試験数 : 16 薬物数 : 43 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 58
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000039686
2020-12-012020-11-05To evaluate the efficacy and safety of tacrolimus in the treatment of children with Henoch Schonlein purpura nephritisA multicentre, randomized, prospective, observational study evaluating the efficacy and safety of tacrolimus in the treatment of Henoch Schonlein purpura nephritis in children at 24 weeks Henoch Schonlein purpura nephritisExperimental drug treatment group:Tacroximus capsule (trade name: Saifu X R), 0.1mg /kg/d, orally taken 1 hour before or 2-3 hours after meals twice a day for 24 weeks;Prednisone 1.5-2mg/kg/d was taken orally for 4 weeks and then changed to oral administration every other day for 4 weeks, gradually reducing the amount.;Control treatment group:Cyclophosphamide 8-10mg/ kg/d was given intravenously for 2 consecutive days, once every 2-4 weeks for 4 consecutive times, and once every 3 weeks for 2 consecutive times for 6 times in total.Prednisone 1.5-2mg/kg/d was taken orally with breakfast in the morning. ;Shengjing Hospital of China Medical UniversityNULLRecruitingBothExperimental drug treatment group:156;Control treatment group:78;Phase 4China
2ChiCTR2200055323
2016-08-012022-01-07Efficacy and safety of tacrolimus in the treatment of children with allergic purpura nephritisEfficacy and safety of tacrolimus in the treatment of children with allergic purpura nephritis Allergic purpuric nephritis in childrenTacrolimus group:Tacrolimus;Cyclophosphamide group:Cyclophosphamide;Mycophenolate mofetil group:Mycophenolate mofetil;Lanzhou University Second HospitalNULLCompleted418BothTacrolimus group:31;Cyclophosphamide group:31;Mycophenolate mofetil group:30;Phase 4China
3NCT03222687
(ClinicalTrials.gov)
September 1, 20157/7/2017Tacrolimus in Children With Henoch-Schönlein Purpura NephritisOff-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and SafetyHenoch-Schönlein Purpura NephritisDrug: tacrolimus;Drug: prednisoneShandong UniversityNULLCompletedN/A18 YearsAll25Phase 4NULL

226. 間質性膀胱炎(ハンナ型)


臨床試験数 : 145 薬物数 : 156 - (DrugBank : 51) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-001501-42-FI
(EUCTR)
15/05/200818/03/2008Tacrolimus in the treatment of Painful Bladder Syndrome / Interstitial CystitisTacrolimus in the treatment of Painful Bladder Syndrome / Interstitial Cystitis Painful bladder syndrome / interstitial cystitis (PBS/IC)
MedDRA version: 1;Level: LLT;Classification code 10005063;Term:
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Jukka SairanenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Finland

227. オスラー病


臨床試験数 : 56 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 136
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04646356
(ClinicalTrials.gov)
October 20, 202020/10/2020Tacrolimus Trial for Hereditary Hemorrhagic Telangiectasia (HHT)Tacrolimus Trial for Hereditary Hemorrhagic Telangiectasia (HHT)Hereditary Hemorrhagic Telangiectasia;Epistaxis NosebleedDrug: Tacrolimus capsule (low-dose)Unity Health TorontoUnited States Department of DefenseRecruiting18 YearsN/AAll30Phase 2Canada
2EUCTR2019-003585-40-NL
(EUCTR)
17/12/201930/09/2019Tacrolimus for bleeding in hereditary hemorrhagic telangiectasia patientsAn uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia - Tacrolimus for bleeding in HHT patients Gastrointestinal bleeding and epistaxis caused by hereditary hemorrhagic telangiectasia. Hereditary Hemorrhagic Telangiectasia (HHT) is an autosomal dominant inherited disease characterized by mucocutaneous telangiectasis. Telangiectasis predominantly observed in the nasal mucosa and gut, and are abnormal, thin walled blood vessel that can easily rupture leading to hemorrhage.
MedDRA version: 20.0;Level: LLT;Classification code 10038554;Term: Rendu-Osler-Weber syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Tacrolimus (Advagraf)
Product Name: Tacrolimus (Advagraf)
Product Code: EMEA/H/C/000712
St. Antonius HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01429844
(ClinicalTrials.gov)
January 20015/9/2011Tacrolimus Versus Cyclosporine for Immunosuppression After Lung TransplantationRandomized, Open-label, Multi-Center Study Comparing Tacrolimus With Cyclosporin, Both Arms in Combination With Mycophenolate Mofetil and Corticosteroids for Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis Obliterans;ImmunosuppressionDrug: Tacrolimus;Drug: CyclosporineUniversitätsklinikum Hamburg-EppendorfNULLCompleted18 Years66 YearsBoth274Phase 3Australia;Austria;Belgium;Germany;Spain;Switzerland

283. 後天性赤芽球癆


臨床試験数 : 19 薬物数 : 36 - (DrugBank : 23) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04965597
(ClinicalTrials.gov)
April 19, 202221/6/2021Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure DiseasesBone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond SyndromeDrug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life AssessmentFred Hutchinson Cancer CenterBlood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI)Recruiting1 Year49 YearsAll40Phase 2United States
2NCT03918265
(ClinicalTrials.gov)
May 4, 201916/4/2019Tacrolimus Treatment for Refractory Autoimmune CytopeniaTacrolimus Treatment for Refractory Autoimmune CytopeniaAutoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans SyndromeDrug: TacrolimusPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll80Phase 4China
3NCT03540472
(ClinicalTrials.gov)
June 10, 201814/5/2018Tacrolimus Treatment for Refractory PRCATacrolimus Treatment for Refractory Pure Red Cell Aplasia, a Prospective StudyPure Red Cell AplasiaDrug: tacrolimusPeking Union Medical College HospitalNULLUnknown status18 Years80 YearsAll30Phase 4China

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01529827
(ClinicalTrials.gov)
February 28, 20126/2/2012Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body IrradiationAccelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationRoswell Park Cancer InstituteNULLCompleted3 Years75 YearsAll94Phase 2United States

285. ファンコニ貧血


臨床試験数 : 62 薬物数 : 93 - (DrugBank : 30) / 標的遺伝子数 : 30 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States

286. 遺伝性鉄芽球性貧血


臨床試験数 : 7 薬物数 : 20 - (DrugBank : 10) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 43
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04965597
(ClinicalTrials.gov)
April 19, 202221/6/2021Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure DiseasesBone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond SyndromeDrug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life AssessmentFred Hutchinson Cancer CenterBlood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI)Recruiting1 Year49 YearsAll40Phase 2United States

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1EUCTR2020-005224-12-NL
(EUCTR)
01/05/202104/01/2021Kaftrio in cystic fibrosis patients currently using tacrolimus, a drug drug interaction studyElexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study - Kaftac cystic fibrosis patients;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: KaftrioHaga Teaching HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 4Netherlands
2EUCTR2009-014050-15-BE
(EUCTR)
18/09/200914/09/2009Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XLConversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant
MedDRA version: 12.0;Level: LLT;Classification code 10025127;Term: Lung transplant
Trade Name: Prograft capsules
Product Name: Tacrolimus capsules
INN or Proposed INN: TACROLIMUS
INN or Proposed INN: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Trade Name: Advagraf prolonged-release hard capsules
Product Name: Tacrolimus prolonged-release hard capsules
Hopital Erasme - Chest serviceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
3NCT00975663
(ClinicalTrials.gov)
September 200910/9/2009Bayesian Dose Adjustment of Immunosuppressants After Lung TransplantationEvaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic FibrosisLung and Heart-lung TransplantationDrug: Tacrolimus and MMFUniversity Hospital, LimogesNULLTerminated18 YearsN/ABoth180Phase 4Belgium;France