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

This study has been terminated.
(The trial was terminated because of deviations from the protocol.)
Sponsor:
Collaborator:
AESCA Pharma GmbH
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00279565
First received: January 17, 2006
Last updated: November 21, 2012
Last verified: February 2007
  Purpose

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 Intervention Phase
Hepatitis C, Chronic
Drug: buprenorphine
Drug: methadone
Drug: pegylated interferon alfa-2b plus ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Estimated Enrollment: 128
Study Start Date: August 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00279565     History of Changes
Other Study ID Numbers: P04279
Study First Received: January 17, 2006
Last Updated: November 21, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
buprenorphine
methadone
Peg-Intron
Rebetol

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Buprenorphine
Methadone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on April 20, 2014