Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: buprenorphine
* Drug: methadone
* Drug: pegylated interferon alfa-2b plus ribavirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: buprenorphine|nan|
|Drug: methadone|nan|
|Drug: pegylated interferon alfa-2b plus ribavirin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buprenorphine, methadone, Peg-Intron, Rebetol