Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol

• Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)

• Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase [ALT]) levels above the upper normal limit for gender

• Documented chronic hepatitis C (CHC) of genotype 1/4/5/6

• A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4

Exclusion Criteria:

• Known hypersensitivity for any active ingredient or constituent

• Pregnancy or lactation

• Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt

• Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months

• Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute

• Hepatitis of immunologic origin or medically documented history of auto-immune disease

• Severe hepatic disorder or decompensated cirrhosis

• Pre-existing thyroid disorder, except if under control with classical treatment

• Epilepsy or central nervous system disorder

• Hemoglobin pathology, eg, thalassaemia, sickle cell anemia