A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2002 |
| End Date: | August 2006 |
An Open-label Study of the Safety and Tolerability of PEGASYS Plus Ribavirin in Patients With Chronic Hepatitis C Viral Infection Who Could Not Tolerate or Were Unresponsive to PEG-Intron Plus Ribavirin
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in
patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with
PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the
target sample size is >100 individuals.
patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with
PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the
target sample size is >100 individuals.
Inclusion Criteria:
- adult patients at least 18 years of age
- CHC infection, genotype 1
- unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks
of treatment
- use of 2 forms of contraception during the study in both men and women
Exclusion Criteria:
- women who are pregnant or breast-feeding
- medical condition associated with chronic liver disease (eg, hemochromatosis,
autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- patients with decompensated cirrhosis
- patients receiving any systemic antiviral therapy or investigational drug, other than
PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
We found this trial at
25
sites
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