95. 自己免疫性肝炎 Autoimmune hepatitis Clinical trials / Disease details


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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05569759
(ClinicalTrials.gov)
January 202329/9/2022A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients With Autoimmune HepatitisAutoimmune HepatitisDrug: zetomipzomib;Drug: placeboKezar Life Sciences, Inc.NULLRecruiting18 YearsN/AAll24Phase 2United States
2EUCTR2020-003990-23-DE
(EUCTR)
21/06/202117/02/2021A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisA DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWINGSTEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS 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: IgG IL2/RO7049665
Product Code: RO7049665
INN or Proposed INN: NA
Other descriptive name: RO7049665/IgG-IL2/ IgG-IL2ND2
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
84Phase 2Portugal;Canada;Australia;Netherlands;Germany;United Kingdom;Italy;New Zealand;Korea, Republic of
3EUCTR2020-003990-23-PT
(EUCTR)
18/06/202112/03/2021A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisA DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWINGSTEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders
Product Name: IgG IL2/RO7049665
Product Code: RO7049665
INN or Proposed INN: NA
Other descriptive name: RO7049665/IgG-IL2/ IgG-IL2ND2
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
84Phase 2Portugal;Canada;Australia;Netherlands;Germany;United Kingdom;Italy;New Zealand;Korea, Republic of
4NCT04376528
(ClinicalTrials.gov)
June 16, 20213/5/2020Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard TherapyMycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard TherapyHepatitis, Autoimmune;Primary Biliary Cholangitis;ImmunosuppressionDrug: Cyclosporin A;Drug: Mycophenolate MofetilWest China HospitalNULLRecruiting18 Years70 YearsAll89Phase 4China
5NCT04933292
(ClinicalTrials.gov)
June 16, 20211/5/2020A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap SyndromeA Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap SyndromeAutoimmune Hepatitis;Primary Biliary CirrhosisDrug: Methylprednisolone and Mycophenolate mofetil;Drug: Methylprednisolone and azathioprineXiaoli FanNULLRecruiting18 Years70 YearsAll78Phase 4China
6NCT04902807
(ClinicalTrials.gov)
June 202121/5/2021Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationConception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationAutoimmune Lymphoproliferative Syndrome;Autoimmune Cytopenia;Autoimmune Diseases;Autoimmune Anemia;Autoimmune Thrombocytopenia;Autoimmune Hepatitis;Autoimmune Diabetes;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Juvenile Idiopathic Arthritis;Hemophagocytic Lymphohistiocytoses;EBV Lymphoproliferation;RAS-Associated Autoimmune Leucoproliferative Disease;Primary Immunodeficiency;APECED;IPEX;BENTA;Enteropathy, Autoimmune;Combined Immunodeficiency;IBDBiological: Collection of samplesInstitut National de la Santé Et de la Recherche Médicale, FranceNULLNot yet recruiting1 Year18 YearsAll500NULL
7EUCTR2020-003990-23-NL
(EUCTR)
28/04/202122/02/2021A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisA DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWINGSTEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS 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] - Hormonal diseases [C19]
Product Name: IgG IL2/RO7049665
Product Code: RO7049665
INN or Proposed INN: NA
Other descriptive name: RO7049665/IgG-IL2/ IgG-IL2ND2
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
84Phase 2Portugal;Canada;Australia;Germany;Netherlands;United Kingdom;Italy;New Zealand;Korea, Republic of
8NCT04790916
(ClinicalTrials.gov)
April 19, 20218/3/2021Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)A Double-Blind, Randomized, Parallel-Group, Phase 2 Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisAutoimmune Hepatitis;Autoimmune Chronic HepatitisDrug: RO7049665;Other: PlaceboHoffmann-La RocheNULLTerminated18 Years75 YearsAll2Phase 2Australia;Canada;Germany;Italy;Korea, Republic of;Netherlands;Portugal;United Kingdom
9EUCTR2020-003990-23-IT
(EUCTR)
11/03/202120/05/2021A Study to Investigate the Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Patients With Autoimmune HepatitisA DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS - - 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] - Hormonal diseases [C19]
Product Name: IgG IL2/RO7049665
Product Code: [RO7049665]
Other descriptive name: RO7049665/IgG-IL2/ IgG-IL2ND2
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
84Phase 2Portugal;Canada;Korea, Democratic People's Republic of;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy;Korea, Republic of
10NCT04371718
(ClinicalTrials.gov)
November 202029/4/2020Effect 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 HepatitisDrug: JKB-122;Other: PlaceboTaiwanJ Pharmaceuticals Co., LtdNULLNot yet recruiting18 Years65 YearsAll120Phase 2NULL
11NCT04313205
(ClinicalTrials.gov)
August 202016/3/2020A Pharmacokinetic Study of JKB-122 Tablets Compared to CapsuleA Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male SubjectsAutoimmune HepatitisDrug: JKB-122 in capsule or tablet formTaiwanJ Pharmaceuticals Co., LtdNULLNot yet recruiting20 Years45 YearsMale8Phase 1NULL
12ChiCTR2000031051
2020-05-012020-03-21Study on the early diagnosis and prediction model of autoimmune hepatitis based on noninvasive clinical dataStudy on the early diagnosis and prediction model of autoimmune hepatitis based on noninvasive clinical data Autoimmune hepatitisGold 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 UniversityNULLPendingMaleTarget condition:238;Difficult condition:0China
13NCT04203875
(ClinicalTrials.gov)
March 9, 202012/12/2019Abatacept for Treatment of Recurrent or de Novo Autoimmune HepatitisAbatacept for Treatment of Recurrent or de Novo Autoimmune HepatitisAutoimmune HepatitisDrug: Orencia® (Abatacept)Stuart Knechtle, M.D.NULLRecruiting18 YearsN/AAll5Phase 1United States
14EUCTR2018-003381-14-SE
(EUCTR)
19/02/202011/12/2019Budesonide compared to prednisolone for the treatment of autoimmunehepatitis - A prospective randomized multicenter studyBudesonide versus Prednisolone as Primary Treatment for AutoimmuneHepatitis: An Open-label, Randomized, Prospective Multicenter 12-monthClinical Trial Evaluating Effect and Side-Effects. - AIHBUDPRED Autoimmune hepatitis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Prednisolon
Product Name: Prednisolon
Trade Name: Budesonid
Product Name: Various
Umeå University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
15JPRN-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
16NCT04129489
(ClinicalTrials.gov)
February 7, 201918/3/2019A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune HepatitisA 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 HepatitisAutoimmune HepatitisDrug: CannabidiolStero Biotechs Ltd.NULLTerminated18 YearsN/AAll2Phase 2Israel
17NCT03842254
(ClinicalTrials.gov)
January 25, 201912/2/2019Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver DiseaseUse of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver DiseaseAutoimmune HepatitisDrug: ErythropoietinNorthwestern UniversityMount Sinai Hospital, New York;Icahn School of Medicine at Mount SinaiCompleted18 Years74 YearsAll6Early Phase 1United States
18NCT03593460
(ClinicalTrials.gov)
January 1, 20197/6/2018Phase II AutoImmune HepatitisPhase II, Open Label, Adaptive Design, Multiple Dose Finding Study to Investigate Synthetic PreImplantation Factor (sPIF) in Patients With Autoimmune Hepatitis (AIH)Hepatitis, AutoimmuneDrug: Synthetic PreImplantation FactorChristopher O'Brien, MDBioIncept LLCWithdrawn18 Years75 YearsAll0Phase 2NULL
19NCT02997878
(ClinicalTrials.gov)
December 7, 201813/12/2016Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIHAn 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 HepatitisCholangitis, Sclerosing;Hepatitis, AutoimmuneBiological: Orbcel-CUniversity of BirminghamNHS Blood and TransplantRecruiting18 YearsN/AAll18Phase 1/Phase 2United Kingdom
20EUCTR2017-001555-32-DK
(EUCTR)
08/06/201808/06/2018A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
21EUCTR2017-001555-32-NL
(EUCTR)
26/04/201818/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Japan;Sweden
22EUCTR2017-001555-32-BE
(EUCTR)
19/03/201818/12/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
65Phase 2;Phase 3Argentina;Singapore;United States;Czechia;Japan;United Kingdom;Switzerland;Spain;Canada;Sweden;Czech Republic;Belgium;Denmark;Germany
23JPRN-UMIN000031353
2018/03/0120/02/2018Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitisEfficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis - Zoledronic acid hydrate and autoimmune hepatitis Autoimmune hepatitisZoledronic acid hydrate group
Other bisphosphonates group
Hyogo college of medicineNULLPending20years-oldNot applicableMale and Female40Not applicableJapan
24NCT03217422
(ClinicalTrials.gov)
February 15, 201812/7/2017ADCC Mediated B-Cell dEpletion and BAFF-R BlockadeA Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune HepatitisAutoimmune HepatitisBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years75 YearsAll65Phase 2/Phase 3United States;Argentina;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Singapore;Spain;Sweden;Switzerland;United Kingdom
25EUCTR2016-001038-91-BE
(EUCTR)
12/02/201830/06/2017A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitisA 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 centreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 4Belgium;Netherlands
26EUCTR2017-001555-32-DE
(EUCTR)
01/02/201812/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden
27EUCTR2017-001555-32-GB
(EUCTR)
16/01/201820/11/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Netherlands;Germany;Japan;Sweden
28EUCTR2017-003311-19-DE
(EUCTR)
09/01/201818/09/2017Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-MABPhase 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-EppendorfNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Germany
29EUCTR2017-001555-32-SE
(EUCTR)
19/12/201702/11/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
30EUCTR2017-001555-32-ES
(EUCTR)
13/11/201711/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
31NCT02900443
(ClinicalTrials.gov)
January 201717/8/2016Mycophenolate Mofetil Versus Azathioprine in Treatment Naive Autoimmune HepatitisA Randomised, Open-label Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Naive Autoimmune HepatitisAutoimmune HepatitisDrug: Mycophenolate mofetil;Drug: AzathioprineRadboud University Medical CenterLeiden University Medical CenterRecruiting18 YearsN/AAll70Phase 4Belgium;Netherlands
32NCT02936596
(ClinicalTrials.gov)
December 201615/10/2016Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap SyndromeBiochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive AgentsHepatitis, Autoimmune;Cholangitis;Liver Cirrhosis, Biliary;CholestasisDrug: Ursodeoxycholic acid combination of immunosuppressive agents;Drug: Ursodeoxycholic AcidXiaoli FanNULLRecruiting18 Years75 YearsAll53N/AChina
33EUCTR2016-001038-91-NL
(EUCTR)
18/11/201625/10/2016A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitisA 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 centreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
34NCT02556372
(ClinicalTrials.gov)
April 30, 201620/9/2015Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current TherapiesA Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current TherapiesAutoimmune HepatitisDrug: JKB-122TaiwanJ Pharmaceuticals Co., LtdNULLCompleted18 YearsN/AAll20Phase 2United States
35NCT02704338
(ClinicalTrials.gov)
April 201628/2/2016Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune HepatitisPhase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune HepatitisAutoimmune DiseasesBiological: Regulatory T cellsNanjing Medical UniversityNULLNot yet recruiting10 Years70 YearsBoth30Phase 1/Phase 2NULL
36NCT02239562
(ClinicalTrials.gov)
November 14, 201410/9/2014sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITISA 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 HepatitisAutoimmune HepatitisDrug: sPIF;Drug: PlaceboChristopher O'Brien, MDBioIncept LLCCompleted18 Years70 YearsFemale36Phase 1United States
37JPRN-UMIN000013659
2014/04/0808/04/2014Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) - Efficacy of Denosumab for steroid-induced osteoporosis in patients with 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 MedicineNULLComplete: follow-up continuing20years-old75years-oldMale and Female80Not applicableJapan
38NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid 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 SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaCompleted18 YearsN/AAll81Phase 2France
39NCT01655121
(ClinicalTrials.gov)
January 201212/7/2012Effect of High-protein High-fiber Diet in Patients With Autoimmune HepatitisEffect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune HepatitisAutoimmune Hepatitis;CirrhosisDietary Supplement: High protein high fiber dietInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNULLCompleted20 Years70 YearsBoth40N/AMexico
40EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase 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™-TRAILPhase 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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
41EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase 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™-TRAILPhase 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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
42EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase 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™-TRAILPhase 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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
43EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase 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™-TRAILPhase 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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
44EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase 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™-TRAILPhase 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.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;France;Austria;Netherlands;Germany
45NCT00587119
(ClinicalTrials.gov)
December 200721/12/2007Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune HepatitisOpen-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 HepatitisDrug: BudesonideMayo ClinicNULLWithdrawn21 Years75 YearsBoth0N/AUnited States
46NCT00608894
(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
47NCT01170351
(ClinicalTrials.gov)
December 200524/7/2010Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune HepatitisComparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune HepatitisAutoimmune HepatitisDrug: Cyclosporine-ATehran University of Medical SciencesNULLCompleted16 Years65 YearsAll55Phase 3Iran, Islamic Republic of
48NCT00687180
(ClinicalTrials.gov)
January 200528/5/2008Mycophenolate vs Azathioprin in Autoimmune HepatitisAutoimmune HepatitisDrug: Treatment with mycophenolat mofetil;Drug: Treatment with azathioprinRigshospitalet, DenmarkNULLCompleted18 YearsN/ABothPhase 4Denmark
49NCT02463331
(ClinicalTrials.gov)
May 200318/5/2015Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized TrialPossible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized TrialAutoimmune HepatitisDrug: Chloroquine diphosphate;Drug: prednisone;Drug: azathioprineUniversity of Sao Paulo General HospitalNULLCompleted18 YearsN/AAll57Phase 4NULL
50NCT01980745
(ClinicalTrials.gov)
February 200224/9/2013CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITISDOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITISHepatitis, AutoimmuneDrug: Chloroquine diphosphate 250mg;Drug: PlaceboUniversity of Sao Paulo General HospitalNULLCompleted18 Years70 YearsBoth61Phase 4Brazil
51NCT00838214
(ClinicalTrials.gov)
March 20015/2/2009Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune HepatitisEfficacy 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 StudyAutoimmune HepatitisDrug: budesonide;Drug: prednisoneDr. Falk Pharma GmbHNULLCompleted10 Years70 YearsAll208Phase 2/Phase 3Germany
52EUCTR2017-001555-32-CZ
(EUCTR)
13/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 AGNULLNAFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden