Rapamune ( DrugBank: - )


8 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
60再生不良性貧血4
66IgA腎症1
67多発性嚢胞腎6
84サルコイドーシス1
158結節性硬化症6
278巨大リンパ管奇形(頚部顔面病変)1
280巨大動静脈奇形(頚部顔面又は四肢病変)2

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
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002399-28-IT
(EUCTR)
14/07/201723/01/2018Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosisRapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis - RAP.ALS definite or probable ALS
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RAPAMUNE - 1 MG 100 COMPRESSE RIVESTITE IN BLISTER USO ORALE
Product Name: Rapamune
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Italy

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
1NCT02979873
(ClinicalTrials.gov)
December 19, 20161/12/2016Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive TherapyA Randomized Trial of Sirolimus (Rapamune(R)) for Relapse Prevention in Patients With Severe Aplastic Anemia Responsive to Immunosuppressive TherapySevere Aplastic AnemiaDrug: SirolimusNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting2 YearsN/AAll118Phase 2United States
2EUCTR2006-006577-25-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
3NCT00319878
(ClinicalTrials.gov)
May 200628/4/2006Sirolimus and Cyclosporine for Treatment-Resistant Aplastic AnemiaA Phase I/II Trial of Sirolimus (Rapamune) and Cyclosporine in Patients With Refractory Aplastic AnemiaAnemia, AplasticDrug: Sirolimus;Drug: CyclosporineOffice of Rare Diseases (ORD)Rare Diseases Clinical Research NetworkRecruiting21 YearsN/ABoth52Phase 1/Phase 2United States
4NCT00061360
(ClinicalTrials.gov)
June 26, 200323/5/2003Improving Immunosuppressive Treatment for Patients With Severe Aplastic AnemiaA Randomized Trial of a Novel Immunosuppressive Combination of ATG, CsA and Sirolimus (Rapamune) vs a Slow Taper Cyclosporine Regimen in Subjects With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: ATG+Rapamune+cyclosporine;Drug: ATG+cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 Years110 YearsAll77Phase 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
1EUCTR2005-002610-37-ES
(EUCTR)
05/12/200530/09/2005PILOT TRIAL OF TREATMENT OF POOR-PROGNOSIS IgA NEPHROPATHY WITH LOW EXPOSURE TO SIROLIMUS.Ensayo clínico piloto de tratamiento de la nefropatía IgA con factores de mal pronóstico con dosis bajas de sirolimusPILOT TRIAL OF TREATMENT OF POOR-PROGNOSIS IgA NEPHROPATHY WITH LOW EXPOSURE TO SIROLIMUS.Ensayo clínico piloto de tratamiento de la nefropatía IgA con factores de mal pronóstico con dosis bajas de sirolimus To test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
NEPHROLOGY DEPARTMENT (HOSPITAL UNIVERSITARY OF BELLVITGE)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Spain

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000550-60-AT
(EUCTR)
17/01/201427/11/2013Pulsed oral sirolimus in autosomal dominant polycystic kidney diseasePulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP Study Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Rapamune 1mg tablets
Product Name: Rapamune 1mg tablets
INN or Proposed INN: SIROLIMUS
Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 3Austria
2EUCTR2007-005047-21-IT
(EUCTR)
24/12/200702/07/2008Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA IIEffects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*100CPR RIV 1MG
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE*30CPR RIV 2MG
INN or Proposed INN: Sirolimus
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
3EUCTR2007-006557-25-IT
(EUCTR)
20/12/200718/12/2007RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDYRAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY ADPKD type I
MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders
Trade Name: RAPAMUNE*100CPR RIV 1MG
INN or Proposed INN: Sirolimus
Product Name: Ramipril
INN or Proposed INN: Ramipril
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALENULLNot RecruitingFemale: yes
Male: yes
Italy
4EUCTR2006-003427-37-IT
(EUCTR)
05/02/200727/12/2006Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - NDSirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND Autosomal-Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*30CPR RIV 1MG
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE*30CPR RIV 2MG
INN or Proposed INN: Sirolimus
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
5NCT00286156
(ClinicalTrials.gov)
October 20061/2/2006Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseasesDrug: RapamuneThe Cleveland ClinicWyeth is now a wholly owned subsidiary of PfizerCompleted18 Years75 YearsAll30Phase 1/Phase 2United States
6NCT00346918
(ClinicalTrials.gov)
June 200622/6/2006Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study.Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Sirolimus;Other: StandardUniversity of ZurichNULLCompleted18 Years40 YearsBoth100Phase 3Switzerland

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004930-27-AT
(EUCTR)
05/02/201920/12/2018Sirolimus as treatment for patients with sarcoidosis.Systems medicine analysis of sarcoidosis by targeting mTOR in apilot study of sirolimus as treatment in patients with sarcoidosis Sarcoidosis with cutaneous affections;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Rapamune
INN or Proposed INN: SIROLIMUS
Other descriptive name: Rapamune
Product Name: Sirolimus Ointment
INN or Proposed INN: SIROLIMUS
Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Austria

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
1NCT01853423
(ClinicalTrials.gov)
October 201312/4/2013Tuberous Sclerosis Complex: Facial Angiofibroma Skin CreamTuberous Sclerosis Complex: Facial Angiofibroma Skin CreamFacial AngiofibromaDrug: RapamuneLe Bonheur Children's HospitalPfizer;University of Tennessee Health Science CenterCompleted3 Years45 YearsBoth11Phase 1United States
2EUCTR2011-006308-12-ES
(EUCTR)
16/07/201229/03/2012Clinical trial in patients with tuberous sclerosis for the study of the effects of topical rapamycin in reducing facial tumors associated with the disease ..phase II clinical trial, to study the efficacy and safety of topical rapamycin in reducing facial angiofibromas. Facial tumors (angiofibromas) associated with tuberous sclerosis complex.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Rapamune 1 mg/ml solución oral
INN or Proposed INN: RAPAMUNE
Fundación Investigación Hospital Ramón y CajalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
3EUCTR2010-022655-29-NL
(EUCTR)
30/05/201122/10/2010Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATERandomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATE Epilepsy in children with Tuberous Sclerosis ComplexTrade Name: RapamuneErasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
4EUCTR2007-005978-30-ES
(EUCTR)
22/01/200803/12/2007Ensayo clínico para evaluar la eficacia y seguridad de la rapamicina en los angiomiolipomas en pacientes con esclerosis tuberosaClinical Trial to Determine the Efficacy and Safety of Rapamycin in Angiomyolipomas in Pacients with Tuberous SclerosisEnsayo clínico para evaluar la eficacia y seguridad de la rapamicina en los angiomiolipomas en pacientes con esclerosis tuberosaClinical Trial to Determine the Efficacy and Safety of Rapamycin in Angiomyolipomas in Pacients with Tuberous Sclerosis Angiomiolipomas en pacientes con esclerosis tuberosa (angiomyolipoma of tuberous sclerosis patients)
MedDRA version: 9.1;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: sirolimus
FUNDACIÓ PUIGVERTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
5EUCTR2021-004548-64-PL
(EUCTR)
08/12/2022Placebo controlled study to assess the efficacy and safety of rapamycin in drug resistant epilepsy associated with tuberous sclerosis complexMulticenter, randomized, double-blind, placebo controlled study to assess the efficacy and safety of Rapamycin in drug Resistant Epilepsy associated with TSC (RaRE-TS) - RaRE-TS tuberous sclerosis complex, epilepsy, organ tumors associated with tuberous sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Rapamune 1 mg/ml oral solutionThe Children's Memorial Health InstituteNULLNAFemale: yes
Male: yes
200Phase 3Poland
6EUCTR2020-003231-19-PL
(EUCTR)
09/10/2020Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous Sclerosis Complex symptoms in infants in the randomized clinical trialRandomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with Tuberous Sclerosis Complex (ViRap) - ViRap Tuberous Sclerosis ComplexEpilepsyTumors associated with Tuberous Sclerosis Complex;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: SABRIL 500 mg, granules for oral solution
Trade Name: RAPAMUNE 1 mg/ml oral solution
The Children's Memorial Health InstituteNULLNAFemale: yes
Male: yes
60Phase 2;Phase 3Poland

278. 巨大リンパ管奇形(頚部顔面病変)


臨床試験数 : 19 薬物数 : 22 - (DrugBank : 7) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 63
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001530-33-FR
(EUCTR)
29/06/201901/04/2019TOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUNTOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUN - TOPGUN Lingual microcystic lymphatic malformations (LMLM) in children and adults
MedDRA version: 20.0;Level: LLT;Classification code 10003229;Term: Arteriovenous malformations;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: RAPAMUNE
Product Name: Sirolimus 1mg/mL
Product Code: L04AA10
CHRU TOURSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance

280. 巨大動静脈奇形(頚部顔面又は四肢病変)


臨床試験数 : 27 薬物数 : 30 - (DrugBank : 15) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 153
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001530-33-FR
(EUCTR)
29/06/201901/04/2019TOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUNTOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUN - TOPGUN Lingual microcystic lymphatic malformations (LMLM) in children and adults
MedDRA version: 20.0;Level: LLT;Classification code 10003229;Term: Arteriovenous malformations;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: RAPAMUNE
Product Name: Sirolimus 1mg/mL
Product Code: L04AA10
CHRU TOURSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
2NCT02042326
(ClinicalTrials.gov)
September 12, 201420/1/2014Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous MalformationsProspective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous MalformationsArteriovenous MalformationsDrug: SirolimusCentre Hospitalier Universitaire, AmiensNULLRecruiting2 YearsN/AAll50Phase 2Belgium;France