CompletedPhase 4

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

Mexico14 participantsStarted 2003-06

Plain-language summary

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male patients, \>=18 years of age; * hemophilia A; * chronic hepatitis C; * compensated liver disease. Exclusion Criteria: * therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months before start of study drug; * hepatitis A, hepatitis B or HIV infection; * chronic liver disease other than chronic hepatitis C.

What they're measuring

SVR

Timeframe: Week 72

Trial details

NCT IDNCT00475072

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-07

View on ClinicalTrials.gov More Hepatitis C, Chronic trials