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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279565
Recruitment Status : Terminated (The trial was terminated because of deviations from the protocol.)
First Posted : January 19, 2006
Last Update Posted : November 22, 2012
AESCA Pharma GmbH
Information provided by (Responsible Party):
Indivior Inc.

January 17, 2006
January 19, 2006
November 22, 2012
August 2005
February 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00279565 on Archive Site
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Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: buprenorphine
  • Drug: methadone
  • Drug: pegylated interferon alfa-2b plus ribavirin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2007
February 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Indivior Inc.
Indivior Inc.
AESCA Pharma GmbH
Not Provided
Indivior Inc.
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP