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 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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN0000307432019/03/3123 April 2019Efficacy 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 HepatitisAutoimmune HepatitisTacrolimusHiroshima University HospitalRecruiting20years-old80years-oldMale and Female5Not selectedJapan
2NCT04129489February 7, 201928 October 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.Recruiting18 YearsN/AAll15Phase 2Israel
3NCT03842254January 25, 20194 March 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 SinaiRecruiting18 Years74 YearsAll10Early Phase 1United States
4NCT03593460January 1, 201914 January 2019Phase 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 LLCNot recruiting18 Years75 YearsAll0Phase 2
5NCT02997878December 7, 201825 February 2019A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & 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 BirminghamEuropean Union;NHS Blood and TransplantRecruiting18 Years70 YearsAll56Phase 1/Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN0000313532018/03/012 April 2019Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitisAutoimmune hepatitisZoledronic acid hydrate group
Other bisphosphonates group
Hyogo college of medicineNot Recruiting20years-oldNot applicableMale and Female40Not applicableJapan
7NCT03217422February 15, 201824 June 2019ADCC 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 PharmaceuticalsRecruiting18 Years75 YearsAll80Phase 2/Phase 3United States;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Spain;Sweden;Switzerland;United Kingdom
8EUCTR2016-001038-91-BE12/02/201812 March 2018A 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 - CAMAROAutoimmune 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 centreAuthorisedFemale: yes
Male: yes
70Phase 4Belgium;Netherlands
9EUCTR2017-003311-19-DE09/01/201822 January 2018Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MABPhase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MABAutoimmune 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-EppendorfAuthorisedFemale: yes
Male: yes
12Phase 2Germany
10NCT02900443January 201711 June 2018Mycophenolate 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 UniversityLeiden University Medical CenterRecruiting18 YearsN/AAll70Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02936596December 20164 March 2019Remission 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 FanRecruiting18 Years75 YearsAll53N/AChina
12EUCTR2016-001038-91-NL18/11/20165 December 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 - CAMAROAutoimmune 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 centreAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
13NCT02704338April 201611 April 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 UniversityNot recruiting10 Years70 YearsBoth30Phase 1/Phase 2
14NCT02556372February 201624 September 2018Liver Test Study of Using JKB-122 in AIH PatientsA 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., LtdNot recruiting18 YearsN/AAll20Phase 2United States
15NCT03069976January 201623 April 2019Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in ChildrenOverlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in ChildrenPrimary Sclerosing Cholangitis;Autoimmune Hepatitis;Overlap SyndromeDrug: MetronidazoleCliniques universitaires Saint-Luc- Université Catholique de LouvainRecruiting3 Years25 YearsAll20N/ABelgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02239562August 201416 December 2017sPIF CLINICAL STUDY PROTOCOL FOR 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'BrienBioIncept LLCNot recruiting18 Years70 YearsFemale18Phase 1United States
17JPRN-UMIN0000136592014/04/082 April 2019Efficacy 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 MedicineNot Recruiting20years-old75years-oldMale and Female80Not applicableJapan
18NCT01988506January 6, 201427 August 2018Induction 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 PharmaRecruiting18 YearsN/AAll132Phase 2France
19NCT01655121January 201219 February 2015Effect 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 ZubiranNot recruiting20 Years70 YearsBoth40N/AMexico
20EUCTR2007-001377-28-FR11/06/200819 March 2012Phase 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™-TRAILAdult 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.AuthorisedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00587119December 200719 February 2015Oral 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 ClinicNot recruiting21 Years75 YearsBoth0N/AUnited States
22NCT00608894December 200719 February 2015LCP-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 PharmaceuticalsNot recruiting18 YearsN/ABoth60Phase 2United States;Canada
23NCT01170351December 200529 July 2019Cyclosporine-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 SciencesNot recruiting16 Years65 YearsAll55Phase 3Iran, Islamic Republic of
24NCT00687180January 200519 February 2015Mycophenolate vs Azathioprin in Autoimmune HepatitisAutoimmune HepatitisDrug: Treatment with mycophenolat mofetil;Drug: Treatment with azathioprinRigshospitalet, DenmarkNot recruiting18 YearsN/ABothPhase 4Denmark
25NCT02463331May 200319 October 2017Possible 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 HospitalNot recruiting18 YearsN/AAll57Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01980745February 20027 November 2016CHLOROQUINE 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 HospitalNot recruiting18 Years70 YearsBoth61Phase 4Brazil
27NCT00838214March 200120 May 2019Budesonide 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 GmbHNot recruiting10 Years70 YearsAll208Phase 2/Phase 3Germany

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