95. 自己免疫性肝炎
［臨床試験数：44，薬物数：57（DrugBank：26），標的遺伝子数：18，標的パスウェイ数：108］
Searched query = "Autoimmune hepatitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04371718 (ClinicalTrials.gov) | November 2020 | 29/4/2020 | Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) | A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH) | Autoimmune Hepatitis | Drug: JKB-122;Other: Placebo | TaiwanJ Pharmaceuticals Co., Ltd | NULL | Not yet recruiting | 18 Years | 65 Years | All | 120 | Phase 2 | NULL |
| 2 | NCT04313205 (ClinicalTrials.gov) | August 2020 | 16/3/2020 | A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule | A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects | Autoimmune Hepatitis | Drug: JKB-122 in capsule or tablet form | TaiwanJ Pharmaceuticals Co., Ltd | NULL | Not yet recruiting | 20 Years | 45 Years | Male | 8 | Phase 1 | NULL |
| 3 | NCT04376528 (ClinicalTrials.gov) | May 30, 2020 | 3/5/2020 | Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy | Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy | Hepatitis, Autoimmune;Primary Biliary Cholangitis;Immunosuppression | Drug: Cyclosporin A;Drug: Mycophenolate Mofetil | West China Hospital | NULL | Not yet recruiting | 18 Years | 70 Years | All | 89 | Phase 4 | NULL |
| 4 | ChiCTR2000031051 | 2020-05-01 | 2020-03-21 | Study on the early diagnosis and prediction model of autoimmune hepatitis based on noninvasive clinical data | Study on the early diagnosis and prediction model of autoimmune hepatitis based on noninvasive clinical data | Autoimmune hepatitis | Gold Standard:liver biopsy;Index test:the early diagnosis and prediction model of autoimmune hepatitis based on noninvasive clinical data; | The Sixth People's Hospital Affiliated To Shanghai Jiaotong University | NULL | Pending | Male | Target condition:238;Difficult condition:0 | China | |||
| 5 | NCT04203875 (ClinicalTrials.gov) | March 9, 2020 | 12/12/2019 | Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis | Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: Orencia® (Abatacept) | Stuart Knechtle, M.D. | NULL | Recruiting | 18 Years | N/A | All | 5 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-UMIN000030743 | 2019/03/31 | 15/01/2018 | 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 | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan |
| 7 | NCT04129489 (ClinicalTrials.gov) | February 7, 2019 | 18/3/2019 | 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. | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | Israel |
| 8 | NCT03842254 (ClinicalTrials.gov) | January 25, 2019 | 12/2/2019 | 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 | Enrolling by invitation | 18 Years | 74 Years | All | 10 | Early Phase 1 | United States |
| 9 | NCT03593460 (ClinicalTrials.gov) | January 1, 2019 | 7/6/2018 | 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 | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 10 | NCT02997878 (ClinicalTrials.gov) | December 7, 2018 | 13/12/2016 | 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_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2017-001555-32-DK (EUCTR) | 08/06/2018 | 08/06/2018 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | |||
| 12 | EUCTR2017-001555-32-NL (EUCTR) | 26/04/2018 | 18/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Japan;Sweden | ||
| 13 | EUCTR2017-001555-32-BE (EUCTR) | 19/03/2018 | 18/12/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 14 | JPRN-UMIN000031353 | 2018/03/01 | 20/02/2018 | 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 | NULL | Pending | 20years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 15 | NCT03217422 (ClinicalTrials.gov) | February 15, 2018 | 12/7/2017 | 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 | NULL | Recruiting | 18 Years | 75 Years | All | 80 | Phase 2;Phase 3 | United States;Argentina;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Singapore;Spain;Sweden;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2016-001038-91-BE (EUCTR) | 12/02/2018 | 30/06/2017 | 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 INN or Proposed INN: mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: azathioprine Product Name: azathioprine INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: prednisolone Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE SODIUM SUCCINATE | Leiden university medical centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 4 | Belgium;Netherlands | ||
| 17 | EUCTR2017-001555-32-DE (EUCTR) | 01/02/2018 | 12/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Spain;Switzerland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 18 | EUCTR2017-001555-32-GB (EUCTR) | 16/01/2018 | 20/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 19 | EUCTR2017-003311-19-DE (EUCTR) | 09/01/2018 | 18/09/2017 | Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-MAB | Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-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) | University Medical Centre Hamburg-Eppendorf | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Germany | ||
| 20 | EUCTR2017-001555-32-SE (EUCTR) | 19/12/2017 | 02/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2017-001555-32-ES (EUCTR) | 13/11/2017 | 11/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.0;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: anti-BAFFr antibody | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 22 | NCT02900443 (ClinicalTrials.gov) | January 2017 | 17/8/2016 | 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 | Unknown status | 18 Years | N/A | All | 70 | Phase 4 | Netherlands |
| 23 | NCT02936596 (ClinicalTrials.gov) | December 2016 | 15/10/2016 | 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 | NULL | Recruiting | 18 Years | 75 Years | All | 53 | N/A | China |
| 24 | EUCTR2016-001038-91-NL (EUCTR) | 18/11/2016 | 25/10/2016 | 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 INN or Proposed INN: mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: azathioprine Product Name: azathioprine INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: prednisolone Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE SODIUM SUCCINATE | Leiden university medical centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 25 | NCT02556372 (ClinicalTrials.gov) | April 30, 2016 | 20/9/2015 | Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies | 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 | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02704338 (ClinicalTrials.gov) | April 2016 | 28/2/2016 | 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 | NULL | Not yet recruiting | 10 Years | 70 Years | Both | 30 | Phase 1;Phase 2 | NULL |
| 27 | NCT03069976 (ClinicalTrials.gov) | January 2016 | 28/2/2017 | 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 | NULL | Recruiting | 3 Years | 25 Years | All | 20 | N/A | Belgium |
| 28 | NCT02239562 (ClinicalTrials.gov) | November 14, 2014 | 10/9/2014 | sPIF CLINICAL STUDY PROTOCOL IN 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, MD | BioIncept LLC | Completed | 18 Years | 70 Years | Female | 36 | Phase 1 | United States |
| 29 | JPRN-UMIN000013659 | 2014/04/08 | 08/04/2014 | 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 | NULL | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 80 | Not applicable | Japan | |
| 30 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | 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 | Active, not recruiting | 18 Years | N/A | All | 81 | Phase 2 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01655121 (ClinicalTrials.gov) | January 2012 | 12/7/2012 | 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 | NULL | Completed | 20 Years | 70 Years | Both | 40 | N/A | Mexico |
| 32 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 33 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 34 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 35 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | 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 newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 37 | NCT00608894 (ClinicalTrials.gov) | December 2007 | 23/1/2008 | 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 | NULL | Terminated | 18 Years | N/A | All | 13 | Phase 2 | United States;Canada |
| 38 | NCT00587119 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | 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 | NULL | Withdrawn | 21 Years | 75 Years | Both | 0 | N/A | United States |
| 39 | NCT01170351 (ClinicalTrials.gov) | December 2005 | 24/7/2010 | 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 | NULL | Completed | 16 Years | 65 Years | All | 55 | Phase 3 | Iran, Islamic Republic of |
| 40 | NCT00687180 (ClinicalTrials.gov) | January 2005 | 28/5/2008 | Mycophenolate vs Azathioprin in Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: Treatment with mycophenolat mofetil;Drug: Treatment with azathioprin | Rigshospitalet, Denmark | NULL | Completed | 18 Years | N/A | Both | Phase 4 | Denmark | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02463331 (ClinicalTrials.gov) | May 2003 | 18/5/2015 | 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 | NULL | Completed | 18 Years | N/A | All | 57 | Phase 4 | NULL |
| 42 | NCT01980745 (ClinicalTrials.gov) | February 2002 | 24/9/2013 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 61 | Phase 4 | Brazil |
| 43 | NCT00838214 (ClinicalTrials.gov) | March 2001 | 5/2/2009 | 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 | NULL | Completed | 10 Years | 70 Years | All | 208 | Phase 2;Phase 3 | Germany |
| 44 | EUCTR2017-001555-32-CZ (EUCTR) | 13/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Spain;Switzerland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden |