DDrare: Database of Drug Development for Rare Diseases

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.

Drug = AZATHIOPRINE; Abatacept; Anti-BAFFR antibody; Anti-BAFFr antibody; Azathioprine; Budesonide; Calcium; Cannabidiol; Chloroquine; Chloroquine diphosphate; Chloroquine diphosphate 250mg; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine-A; Denosumab; EFALIZUMAB; Efalizumab; Erythropoietin; Gold; High protein high fiber diet; INTERLEUKIN 2; Ianalumab; Inflectra (Infliximab); Infliximab; Interleukin 2; JKB-122; JKB-122 in capsule or tablet form; LCP-Tacro (tacrolimus); MYCOPHENOLATE MOFETIL; Metronidazole; Minodronic acid; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofeti; Mycophenolate mofetil; Orbcel-C; Orencia® (Abatacept); PREDNISOLONE SODIUM SUCCINATE; Prednisolone; Prednisone; Preimplantation factor; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Regulatory T cells; Risedronic acid; SPIF; Synthetic PreImplantation Factor; Tacrolimus; Treatment with azathioprin; Treatment with mycophenolat mofetil; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ursodeoxycholic acid combination of immunosuppressive agents; VAY736; Vitamin D; Zoledronic acid

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	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

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

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

Phase 1

NULL

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

Phase 2

United States