Randomized, controlled Study of Methadone and Buprenrphine in Hepatitis C patients in need of treatment

• Conditions: hepatitis C patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution

• Registration Number: EUCTR2005-000240-82-AT
• Lead Sponsor: AESCA Pharma GesmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-31
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

male and female patients with a history of iv drug abuse, who are willing to undergo methadone or buprenorphine substitution
patients with newly diagnosed chronic hepatitis C
age 18 - 65
HCV-RNA positive in serum as measured by PCR within the last 4 weeks
genotype 2 or 3
elevated ALT levels

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive
·breast-feeding women
·cirrhosis stage B and C according to Child-Pugh
·confirmed co-infection with HIV or HBV
·existing psychiatric comorbidity
·alcohol abuse
·active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
·existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician)
·treatment with a study drug within the last 30 days
·any uncontrolled underlying medical conditions (e.g. diabetes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified