95. 自己免疫性肝炎 ［臨床試験数：27，薬物数：40（DrugBank：23），標的遺伝子数：16，標的パスウェイ数：100］
Searched query = "Autoimmune hepatitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000030743 | 2019/03/31 | 23 April 2019 | Efficacy 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 Pilot Study - Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis | Autoimmune Hepatitis | Tacrolimus | Hiroshima University Hospital | Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan | |
| 2 | NCT04129489 | February 7, 2019 | 28 October 2019 | A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis | A Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: Cannabidiol | Stero Biotechs Ltd. | Recruiting | 18 Years | N/A | All | 15 | Phase 2 | Israel | |
| 3 | NCT03842254 | January 25, 2019 | 4 March 2019 | Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease | Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease | Autoimmune Hepatitis | Drug: Erythropoietin | Northwestern University | Mount Sinai Hospital, New York;Icahn School of Medicine at Mount Sinai | Recruiting | 18 Years | 74 Years | All | 10 | Early Phase 1 | United States |
| 4 | NCT03593460 | January 1, 2019 | 14 January 2019 | Phase II AutoImmune Hepatitis | Phase II, Open Label, Adaptive Design, Multiple Dose Finding Study to Investigate Synthetic PreImplantation Factor (sPIF) in Patients With Autoimmune Hepatitis (AIH) | Hepatitis, Autoimmune | Drug: Synthetic PreImplantation Factor | Christopher O'Brien, MD | BioIncept LLC | Not recruiting | 18 Years | 75 Years | All | 0 | Phase 2 | |
| 5 | NCT02997878 | December 7, 2018 | 25 February 2019 | A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH | An Adaptive,Multicentre, Phase IIa, Multi-disease Trial Investigating the Safety & Activity of a Single Infusion of Selected Mesenchymal Stromal Cells in the Treatment of Patients With Primary Sclerosing Cholangitis & Autoimmune Hepatitis | Cholangitis, Sclerosing;Hepatitis, Autoimmune | Biological: Orbcel-C | University of Birmingham | European Union;NHS Blood and Transplant | Recruiting | 18 Years | 70 Years | All | 56 | Phase 1/Phase 2 | United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-UMIN000031353 | 2018/03/01 | 2 April 2019 | Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis | Autoimmune hepatitis | Zoledronic acid hydrate group Other bisphosphonates group | Hyogo college of medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | ||
| 7 | NCT03217422 | February 15, 2018 | 24 June 2019 | ADCC Mediated B-Cell dEpletion and BAFF-R Blockade | A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis | Autoimmune Hepatitis | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | Recruiting | 18 Years | 75 Years | All | 80 | Phase 2/Phase 3 | United States;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Spain;Sweden;Switzerland;United Kingdom | |
| 8 | EUCTR2016-001038-91-BE | 12/02/2018 | 12 March 2018 | A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis | A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO | Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: mycophenolate mofeti Product Name: mycophenolate mofetil Pharmaceutical Form: Capsule INN or Proposed INN: mycophenolate mofetil CAS Number: 128794-94-5 Other descriptive name: MYCOPHENOLATE MOFETIL Concentration unit: mg milligram(s) Concentration type: range Concentration number: 500-2000 Trade Name: azathioprine Product Name: azathioprine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50-100 Trade Name: prednisolone Product Name: prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 1715-33-9 Other descriptive name: PREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-40 | Leiden university medical centre | Authorised | Female: yes Male: yes | 70 | Phase 4 | Belgium;Netherlands | |||
| 9 | EUCTR2017-003311-19-DE | 09/01/2018 | 22 January 2018 | Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MAB | Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MAB | Autoimmune Hepatitis (AIH); rare inflammatory liver disease associated with elevated transaminases, elevated Immunoglobulin G, the presence of autoantibodies and interface hepatitis in liver histology. Untreated, AIH progresses to liver fibrosis and cirrhosis with its complications. Historical placebo-controlled studies could show a mortality of around 70% in the placebo-treated group. ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra (Infliximab) Pharmaceutical Form: Concentrate for solution for infusion | University Medical Centre Hamburg-Eppendorf | Authorised | Female: yes Male: yes | 12 | Phase 2 | Germany | |||
| 10 | NCT02900443 | January 2017 | 11 June 2018 | Mycophenolate Mofetil Versus Azathioprine in Treatment Naive Autoimmune Hepatitis | A Randomised, Open-label Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Naive Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: Mycophenolate mofetil;Drug: Azathioprine | Radboud University | Leiden University Medical Center | Recruiting | 18 Years | N/A | All | 70 | Phase 4 | Netherlands |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02936596 | December 2016 | 4 March 2019 | Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome | Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents | Hepatitis, Autoimmune;Cholangitis;Liver Cirrhosis, Biliary;Cholestasis | Drug: Ursodeoxycholic acid combination of immunosuppressive agents;Drug: Ursodeoxycholic Acid | Xiaoli Fan | Recruiting | 18 Years | 75 Years | All | 53 | N/A | China | |
| 12 | EUCTR2016-001038-91-NL | 18/11/2016 | 5 December 2016 | A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis | A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO | Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: mycophenolate mofeti Product Name: mycophenolate mofetil Pharmaceutical Form: Capsule INN or Proposed INN: mycophenolate mofetil CAS Number: 128794-94-5 Other descriptive name: MYCOPHENOLATE MOFETIL Concentration unit: mg milligram(s) Concentration type: range Concentration number: 500-2000 Trade Name: azathioprine Product Name: azathioprine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50-100 Trade Name: prednisolone Product Name: prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 1715-33-9 Other descriptive name: PREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-40 | Leiden university medical centre | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 13 | NCT02704338 | April 2016 | 11 April 2016 | Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis | Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis | Autoimmune Diseases | Biological: Regulatory T cells | Nanjing Medical University | Not recruiting | 10 Years | 70 Years | Both | 30 | Phase 1/Phase 2 | ||
| 14 | NCT02556372 | February 2016 | 24 September 2018 | Liver Test Study of Using JKB-122 in AIH Patients | A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies | Autoimmune Hepatitis | Drug: JKB-122 | TaiwanJ Pharmaceuticals Co., Ltd | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States | |
| 15 | NCT03069976 | January 2016 | 23 April 2019 | Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children | Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in Children | Primary Sclerosing Cholangitis;Autoimmune Hepatitis;Overlap Syndrome | Drug: Metronidazole | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Recruiting | 3 Years | 25 Years | All | 20 | N/A | Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02239562 | August 2014 | 16 December 2017 | sPIF CLINICAL STUDY PROTOCOL FOR AUTOIMMUNE HEPATITIS | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Synthetic PreImplantation Factor (sPIF) in Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: sPIF;Drug: Placebo | Christopher O'Brien | BioIncept LLC | Not recruiting | 18 Years | 70 Years | Female | 18 | Phase 1 | United States |
| 17 | JPRN-UMIN000013659 | 2014/04/08 | 2 April 2019 | Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) | Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months | <Test A; Randomization test: 1)2)> In patients pretreated with bisphosphonates; 1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. <Test A; Randomization test: 1)2)> 2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D. <Test B; newly intervention> In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. | Juntendo University School of Medicine | Not Recruiting | 20years-old | 75years-old | Male and Female | 80 | Not applicable | Japan | ||
| 18 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
| 19 | NCT01655121 | January 2012 | 19 February 2015 | Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis | Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis | Autoimmune Hepatitis;Cirrhosis | Dietary Supplement: High protein high fiber diet | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Not recruiting | 20 Years | 70 Years | Both | 40 | N/A | Mexico | |
| 20 | EUCTR2007-001377-28-FR | 11/06/2008 | 19 March 2012 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome MedDRA version: 9.1 Level: LLT Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Merck Serono International S.A. | Authorised | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT00587119 | December 2007 | 19 February 2015 | Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis | Open-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis. | Primary Biliary Cirrhosis;Autoimmune Hepatitis | Drug: Budesonide | Mayo Clinic | Not recruiting | 21 Years | 75 Years | Both | 0 | N/A | United States | |
| 22 | NCT00608894 | December 2007 | 19 February 2015 | LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis | A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: LCP-Tacro (tacrolimus);Drug: Azathioprine | Veloxis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 60 | Phase 2 | United States;Canada | |
| 23 | NCT01170351 | December 2005 | 29 July 2019 | Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis | Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis | Autoimmune Hepatitis | Drug: Cyclosporine-A | Tehran University of Medical Sciences | Not recruiting | 16 Years | 65 Years | All | 55 | Phase 3 | Iran, Islamic Republic of | |
| 24 | NCT00687180 | January 2005 | 19 February 2015 | Mycophenolate vs Azathioprin in Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: Treatment with mycophenolat mofetil;Drug: Treatment with azathioprin | Rigshospitalet, Denmark | Not recruiting | 18 Years | N/A | Both | Phase 4 | Denmark | |||
| 25 | NCT02463331 | May 2003 | 19 October 2017 | Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial | Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial | Autoimmune Hepatitis | Drug: Chloroquine diphosphate;Drug: prednisone;Drug: azathioprine | University of Sao Paulo General Hospital | Not recruiting | 18 Years | N/A | All | 57 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01980745 | February 2002 | 7 November 2016 | CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS | DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITIS | Hepatitis, Autoimmune | Drug: Chloroquine diphosphate 250mg;Drug: Placebo | University of Sao Paulo General Hospital | Not recruiting | 18 Years | 70 Years | Both | 61 | Phase 4 | Brazil | |
| 27 | NCT00838214 | March 2001 | 20 May 2019 | Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis | Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study | Autoimmune Hepatitis | Drug: budesonide;Drug: prednisone | Dr. Falk Pharma GmbH | Not recruiting | 10 Years | 70 Years | All | 208 | Phase 2/Phase 3 | Germany |