Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

NCT00887263

Oral Chronic Graft vs Host Disease

COMPLETED PHASE3

Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

NCT00807547

Allergy

COMPLETED PHASE3

Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

NCT00857779

Rhinitis Conjunctivitis Asthma

COMPLETED PHASE2

Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects

NCT01171664

Seasonal Allergic Rhinitis

COMPLETED PHASE2

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

NCT02988778

Rhinitis, Allergic, Perennial

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

budesonide

3mg capsules 3x/day for 6 months

Group Type EXPERIMENTAL

budesonide

Intervention Type DRUG

3mg capsule, 3x per day for 6 months

prednisone

5mg tablet, 40mg starting dose titrated to 10mg over 3 months

Group Type ACTIVE_COMPARATOR

prednisone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

budesonide

3mg capsule, 3x per day for 6 months

Intervention Type DRUG

prednisone

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No