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Trial record 5 of 26 for:    "Hepatitis" | "Guaifenesin"

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.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: buprenorphine Drug: methadone Drug: pegylated interferon alfa-2b plus ribavirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
Study Start Date : August 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Indivior Inc. Identifier: NCT00279565     History of Changes
Other Study ID Numbers: P04279
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: February 2007
Keywords provided by Indivior Inc.:
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Antitussive Agents
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs