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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00279565
• Other study ID #: P04279
• Status: Terminated
• Phase: Phase 4
• First received: January 17, 2006
• Last updated: November 21, 2012
• Start date: August 2005
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• buprenorphine

• methadone

• pegylated interferon alfa-2b plus ribavirin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indivior Inc.	AESCA Pharma GmbH