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

Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: buprenorphine (Drug); methadone (Drug); pegylated interferon alfa-2b plus ribavirin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Reckitt Benckiser Pharmaceuticals Inc.


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.

Clinical Details

Official title: Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- Breast-feeding women.

- Cirrhosis stage B and C according to Child-Pugh.

- Signs of decompensated liver disease (ascites, bleeding varices and spontaneous


- Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus


- 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.

Locations and Contacts

Additional Information

Starting date: August 2005
Last updated: November 21, 2012

Page last updated: August 23, 2015

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