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

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
buprenorphine
methadone
pegylated interferon alfa-2b plus ribavirin
Sponsored by
Indivior Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring buprenorphine, methadone, Peg-Intron, Rebetol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2006
    Last Updated
    November 21, 2012
    Sponsor
    Indivior Inc.
    Collaborators
    AESCA Pharma GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00279565
    Brief Title
    Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)
    Official Title
    Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    The trial was terminated because of deviations from the protocol.
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Indivior Inc.
    Collaborators
    AESCA Pharma GmbH

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic
    Keywords
    buprenorphine, methadone, Peg-Intron, Rebetol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    buprenorphine
    Intervention Type
    Drug
    Intervention Name(s)
    methadone
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated interferon alfa-2b plus ribavirin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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