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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Rebetol (ribavirin; SCH 18908); Biological: PegIntron (peginterferon alfa-2b; SCH 54031)

Study type: Observational

Funder types: Industry

Identifiers

NCT00709059

P04243

Details and patient eligibility

About

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.

Enrollment: 538 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

538 participants in 1 patient group

PegIntron Plus Rebetol

Description:

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

Treatment:

Biological: PegIntron (peginterferon alfa-2b; SCH 54031)

Drug: Rebetol (ribavirin; SCH 18908)