Trial information
CEE study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: MV17117
Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/ Roche Global Business
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of PEGASYS on sustained virologic response in patients with chronic hepatitis C receiving ribavirin combination therapy
Brief summary: This study will assess the efficacy and safety of treatment with PEGASYS in combination with ribavirin in naive and previously-treated patients with CHC. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Target sample size is 1335.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Sustained virologic response rate 24 weeks post-treatment in naïve patients
Key secondary outcomes: 1. Sustained virologic response rate in pre-treated patients, % of naïve and pre-treated patients with 2 log drop or negative HCV-RNA at Wk 12, % of naïve and pre-treated patients with non-detectable HCV-RNA at EOT
AE rate and profile"
Inclusion criteria:
- adult patients >=18 years of age;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC disease;
- use of two forms of contraception during study and 6 months after the study in both men and women.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2003
Trial registration date: 07/26/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Bosnia and Herzegovina
Czech Republic
- Beroun
- Brno
- Ceska Lipa
- Ceské Budejovice
- Chomutov
- Chrudim
- Decin
- Havirov
- Havlickuv Brod
- Hradec Kralove
- Jihlava
- Jindrichuv Hradec
- Karlovy Vary
- Kolin
- Kyjov
- Liberec
- Litomerice
- Melnik
- Most
- Olomouc
- Opava
- Ostrava
- Pardubice
- Praha
- Prostejov
- Slany
- Strakonice
- Trinec
- Usti Nad Labem
Macedonia, The Former Yugoslav Republic of
Slovakia
- Banska Bystrica
- Bratislava
- Kosice
- Martin
- Trencin
