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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. )
First Received: January 17, 2006   Last Updated: February 28, 2007   History of Changes
Sponsor: Schering-Plough
Collaborator: AESCA Pharma GmbH
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00279565
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Schering-Plough:

Estimated Enrollment: 128
Study Start Date: August 2005
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279565

Sponsors and Collaborators
Schering-Plough
AESCA Pharma GmbH
Investigators
Principal Investigator: Study Principal Investigator Unaffiliated
  More Information

No publications provided

Study ID Numbers: P04279
Study First Received: January 17, 2006
Last Updated: February 28, 2007
ClinicalTrials.gov Identifier: NCT00279565     History of Changes
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Schering-Plough:
buprenorphine
methadone
Peg-Intron
Rebetol

Additional relevant MeSH terms:
Respiratory System Agents
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Narcotic Antagonists
Physiological Effects of Drugs
Hepatitis, Viral, Human
Buprenorphine
Sensory System Agents
Therapeutic Uses
Analgesics
Growth Inhibitors
Hepatitis C
Angiogenesis Modulating Agents
Analgesics, Opioid
Interferon-alpha
RNA Virus Infections
Growth Substances
Central Nervous System Depressants
Narcotics
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Methadone
Digestive System Diseases

ClinicalTrials.gov processed this record on February 08, 2010