DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
95	自己免疫性肝炎	1

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	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

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

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

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

Phase 2

Germany