Status:
TERMINATED
Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)
Lead Sponsor:
Indivior Inc.
Collaborating Sponsors:
AESCA Pharma GmbH
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00279565
Start Date
August 1 2005
End Date
February 1 2007
Last Update
November 22 2012
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