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

NCT ID: NCT00279565

Last Updated: 2012-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-02-28

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.

Conditions

Hepatitis C, Chronic

Keywords

buprenorphine; methadone; Peg-Intron; Rebetol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

buprenorphine

Intervention Type: DRUG

methadone

Intervention Type: DRUG

pegylated interferon alfa-2b plus ribavirin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AESCA Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Indivior Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

Austria

Other Identifiers

P04279

Identifier Type: -

Identifier Source: org_study_id