PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)

PHASE4CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Hepatitis C, Chronic
Interventions
BIOLOGICAL

Peginterferon alfa-2b (SCH 054031)

All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

DRUG

Ribavirin (SCH 018908)

All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Schering-Plough

INDUSTRY