hepatitis C patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution
Conditions
Interventions
Trade Name: buprenorphine
Product Name: buprenorphine
Pharmaceutical Form: Sublingual tablet
Sponsors
AESCA Pharma GesmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy of hepatitis C treatment in methadone or buprenorphine maintenance patients;Secondary Objective: Quality of life psychical symptoms (Beck Depression Inventory) physical symptoms (Zerssen symptom list, Wang scale) cost-effectiveness (EQ-5D) toxicity;Primary end point(s): Comparison of efficacy of hepatitis C treatment within the two groups of patients (buprenorphine and methadone) | — |
Countries
Austria
Outcome results
None listed