Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
Status: Completed
Protocol number: ML16814
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the safety and effect on sustained virological response of PEGASYS plus ribavirin in patients with hemophilia A and chronic Hepatitis C
Brief 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. Target sample size is 14.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. SVR Time frame: Week 72
Key secondary outcomes: 1. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/17/2007
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Mexico
