Hepatitis C, Chronic
Conditions
Keywords
buprenorphine, methadone, Peg-Intron, Rebetol
Brief summary
This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.
Interventions
DRUGbuprenorphine
DRUGmethadone
DRUGpegylated interferon alfa-2b plus ribavirin
Sponsors
AESCA Pharma GmbH
Indivior Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution. * Patients with newly diagnosed chronic hepatitis C. * Age 18-65. * Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks. * Genotype 2 or 3. * Elevated alanine aminotransferase (ALT) levels. * In women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented. * Lab parameters: * Hemoglobin: \>=12 g/dL (women) or \>=13 g/dL (men) * Leukocytes \>=3,000/µL * Thrombocytes \>=100,000/µL * Prothrombin time (PT)/partial thromboplastin time (PTT)/coagulation within the normal range * Albumin: not more than 10% deviation from lower normal value * Thyroid-stimulating hormone (TSH) normal * Creatinine normal * Uric acid normal * Antinuclear antibodies \<=1:160 * Signed informed consent.
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. * Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy). * Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (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). * Clinically significant electrocardiogram (ECG) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. In case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient. * Any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded). * Autoimmune disorder (except LKM-positive patients: these patients may be included in the study). * Misuse of buprenorphine or methadone.
Outcome results
None listed