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

November 21, 2012 updated by: Indivior Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

128

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indivior Inc.

Collaborators

AESCA Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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