Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

CompletedOBSERVATIONAL
Enrollment

246

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Hepatitis C, ChronicSubstance Abuse, Intravenous
Interventions
BIOLOGICAL

PegIntron (pegylated interferon alfa-2b; SCH 54031)

PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

DRUG

Rebetol (ribavirin; SCH 18908)

Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00726557 - Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261) | Biotech Hunter | Biotech Hunter