Hepatitis C, Chronic
Conditions
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.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
DRUGribavirin
1000/1200mg po daily for 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SVR | Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters. | Throughout study |
Countries
Mexico
Outcome results
None listed