Trial information
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).
Status: Recruiting
Protocol number: ML21543
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to investigate the effect of PEGASYS plus Copegus on sustained virological response in naive patients with chronic hepatitis C, genotype 2 or 3, who have a virological response at week 4
Brief summary: 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. Target sample size is
100.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Sustained virological response Time frame: Week 48
Key secondary outcomes: 1. Sustained virological response 24 weeks after treatment completion Time frame: 24 weeks after last dose of study medication
2. Virological response at end of treatment Time frame: +/- 28 days after last dose of study medication
3. Virological relapse Time frame: Event driven
4. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Brazil
- Brasilia
- Campinas
- Curitiba
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Santo Andre
- Sao Luis
- Sao Paulo
- Sorocaba
- Vitoria
