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Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

NCT00838214 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2019-05-07

No results posted yet for this study

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.

Conditions

  • Autoimmune Hepatitis

Interventions

DRUG

budesonide

3mg capsule, 3x per day for 6 months

DRUG

prednisone

5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Michael M Manns, Professor · University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838214 on ClinicalTrials.gov