Trial information
A Study of Roferon-A (Interferon Alfa-2a) in Patients With Chronic Hepatitis C
Status: Completed
Protocol number: M23153
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Roferon-A plus ribavirin (Copegus) on safety and tolerability in patients with chronic hepatitis C viral infection
Brief summary: This study will evaluate the safety and tolerability of interferon alfa-2a in combination with ribavirin in patients with chronic hepatitis C. Patients who have never received prior interferon therapy, and patients who have relapsed after prior interferon therapy, will be eligible for this trial. the anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Target sample size is 5000.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacodynamics study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: interferon alfa-2a[Roferon-A]
Primary outcome: 1. Safety and tolerability of ribavirin in combination with Roferon-A
Key secondary outcomes: 1. Efficacy: Normalisation of ALT; negative HCV-RNA . Safety: adverse events
Inclusion criteria:
- adult patients 18-75 years of age;
- chronic hepatitis C infection.
Exclusion criteria:
- hepatitis B and/or HIV co-infection;
- fertile males and females not using reliable contraception during the study and for 6 months after treatment with ribavirin.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Bangladesh
Belgium
Brazil
- Botucatu
- Curitiba
- Porto Alegre
- Recife
- Vitoria
Bulgaria
Croatia
Czech Republic
Egypt
Finland
Greece
Hungary
India
Israel
Morocco
New Zealand
Poland
Romania
Slovakia
Slovenia
Taiwan
Venezuela
