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

Phase 4

Terminated

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00279565
• Lead Sponsor: Indivior Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Status Verified: 2007-02
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL