Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT00838214

Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

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

Sponsor: Dr. Falk Pharma GmbH

Conditions Autoimmune Hepatitis

Interventions budesonide prednisone

Updated 6 times since 2017 Last updated: May 3, 2019 Started: Mar 31, 2001 Primary completion: Dec 31, 2008 Completion: Dec 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00838214, this PHASE2/PHASE3 trial focuses on Autoimmune Hepatitis and remains completed. Sponsored by Dr. Falk Pharma GmbH, it has been updated 6 times since 2001, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2/PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2_PHASE3
Jun 2019 — Jan 2021 [monthly]

Completed PHASE2_PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2019 [monthly]

Completed PHASE2_PHASE3

First recorded

Mar 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Dr. Falk Pharma GmbH

Data source: Dr. Falk Pharma GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Hanover, Germany