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

NCT ID: NCT00709059

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 538 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2009-12-31

Brief 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.

Conditions

Hepatitis C, Chronic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PegIntron Plus Rebetol

Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Intervention Type: BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04243

Identifier Type: -

Identifier Source: org_study_id