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

Indivior

Status and phase

Terminated

Phase 4

Conditions

Hepatitis C, Chronic

Treatments

Drug: methadone

Drug: pegylated interferon alfa-2b plus ribavirin

Drug: buprenorphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00279565

P04279

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.