Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

This study has been completed.
Sponsor:
Information provided by:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00838214
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Autoimmune Hepatitis
Drug: budesonide
Drug: prednisone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of biochemical remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: March 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: budesonide
3mg capsules 3x/day for 6 months
Drug: budesonide
3mg capsule, 3x per day for 6 months
Active Comparator: prednisone
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
Drug: prednisone
5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838214

Locations
Germany
Medical School Hannover
Hannover, Niedersachsen, Germany, D-30625
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Michael M Manns, Professor University Hospital
  More Information

No publications provided by Dr. Falk Pharma GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markus Proels, Dr. Falk Pharma, Germany
ClinicalTrials.gov Identifier: NCT00838214     History of Changes
Other Study ID Numbers: BUC-38/AIH
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Israel: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Autoimmune
Autoimmune Diseases
Digestive System Diseases
Enterovirus Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Budesonide
Prednisone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014