Clinical trial NCT00279565: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: buprenorphine
methadone
Peg-Intron
Rebetol
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
Collaborators: name: AESCA Pharma GmbH
First posted: 2006-01-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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