POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).
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Details and patient eligibility
About
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- adult patients, >=18 years of age;
- positive serum HCV RNA.
Exclusion criteria
- co-infection with HIV or HBV (patients with a positive HBsAg);
- previous treatment with interferon, or peginterferon and/or ribavirin;
- severe hepatic dysfunction or decompensated cirrhosis of liver.
Trial design
262 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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