Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Autoimmune Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838214
• Other study ID #: BUC-38/AIH
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2001
• Est. completion date: December 2008

Study information

• Verified date: May 2019
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicentre, multinational clinical study. It comprised two consecutive segments (A and B). Segment A was designed as a randomized, double-blind, double-dummy, active-controlled, two-arm parallel-group study. The patients received either budesonide or prednisone for 6 months. During segment B all patients received budesonide as an open treatment for additional 6 months.

In this confirmatory study the proportion of patients with complete response was compared between the two treatment groups. Complete response was defined as biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment A and lack of steroid specific side effects throughout segment A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 10 to 70 years

• Diagnosis of acute AIH according to Alvarez score

• normal range of TPMT activity

• normal ACTH test

• negative pregnancy test at screening for females of childbearing potential

• written informed consent

Exclusion Criteria:

• presence of Hepatitis A, B, C, E or G virus infection

• liver cirrhosis or clinical signs of portal hypertension

• PBC

• PSC

• history of hypersensitivity to the study medication

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Drug:
• budesonide
3mg capsule, 3x per day for 6 months
• prednisone
5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Manns MP, Woynarowski M, Kreisel W, Lurie Y, Rust C, Zuckerman E, Bahr MJ, Günther R, Hultcrantz RW, Spengler U, Lohse AW, Szalay F, Färkkilä M, Pröls M, Strassburg CP; European AIH-BUC-Study Group. Budesonide induces remission more effectively than predn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of Segment A and lack of steroid specific side effects		6 months
Secondary	incidence of biochemical remission		6 months