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

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

• Registration Number: NCT00709059
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-22
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 538

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PegIntron Plus Rebetol	PegIntron (peginterferon alfa-2b; SCH 54031)	Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.
PegIntron Plus Rebetol	Rebetol (ribavirin; SCH 18908)	Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.

Primary Outcome Measures

Name	Time	Method
Number of Study Participants Who Had a Virological Response (VR) at Week-72	Treatment Week 72	VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.; Participants who dropped out or were withdrawn from treatment were considered not to respond.