Trial information
OST study. A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Monotherapy and Combination Therapy With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: BV16210
Sponsor: F Hoffmann-La Roche Ltd./Inc/AG/ Roche Global Business
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety and tolerability of PEGASYS alone and in combination with ribavirin in patients with chronic hepatitis C
Brief summary: This study will assess the safety, tolerability and efficacy of treatment with PEGASYS alone or in combination with ribavirin in 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 500.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Efficacy: Sustained virologic response rate, sustained biochemical response rate, % of patients with non-detectable HCV-RNA
Safety: Hemoglobin, other laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- either no previous therapy or breakthrough or relapse during or after previous therapy;
- use of 2 forms of contraceptive methods during 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;
- patients who did not respond to previous interferon or interferon plus ribavirin therapy;
- 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
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Aix Les Bains
- Besancon
- Bordeaux
- Bourgoin Jallieu
- Creteil
- Epinay-Sur-Seine
- Grasse
- Grenoble
- Lille
- Lyon
- Montpellier
- Nancy
- Nanterre
- Narbonne
- Ollioules
- Orange
- Paris
- Perpignan
- Reims
- Romans Sur Isere
- Saint Laurent Du Var
- Toulouse
- Valence
- Venissieux
Germany
- Aalen
- Berlin
- Bielefeld
- Celle
- Cottbus
- Erfurt
- Erlangen
- Frankfurt Am Main
- Giessen
- Grenzach-Wyhlen
- Halle
- Hamburg
- Hameln
- Herne
- Jena
- Kassel
- Koblenz
- Leipzig
- Lübeck
- Ludwigshafen
- Magdeburg
- Mannheim
- Minden
- München
- Oberhausen
- Offenburg
- Oldenburg
- Regensburg
- Rostock
- Ruesselsheim
- Siegburg
- Sömmerda
- Tuebingen
- Wiesbaden
- Wuerselen
