Clinical Trial Protocol Registry

Trial information

A Study of Roferon-A (Interferon Alfa-2a) in Patients With Chronic Hepatitis C

Status:
Completed
Protocol number:
M23153
Sponsor:
Hoffmann-La Roche
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 7429.
Study phase:
IV
Study type:
Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Pharmacodynamics study
Conditions:
  • Hepatitis C, Chronic
Primary outcome:
  1. Safety and tolerability of ribavirin in combination with Roferon-A\n
Key secondary outcomes:
  1. Efficacy: Normalisation of ALT; negative HCV-RNA . Safety: adverse events\n
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
Anticipated start date:
May, 1999
Trial registration date:
19.12.2005
Date last updated:
04.06.2013
This trial was conducted at the following locations:
Bangladesh
  • DHAKA
Belgium
  • BRUXELLES
Brazil
  • BOTUCATU
  • CURITIBA
  • PORTO ALEGRE
  • RECIFE
  • VITORIA
Bulgaria
  • SOFIA
Croatia
  • ZAGREB
Czech Republic
  • PRAHA
Egypt
  • GIZA
Finland
  • ESPOO
Greece
  • MAROUSSI
Hungary
  • BUDAOERS
India
  • MUMBAI
Israel
  • PETACH TIKVA
Morocco
  • CASABLANCA
New Zealand
  • AUCKLAND
Poland
  • WARSZAWA
Romania
  • BUCHAREST
Serbia
  • BELGRADE
Slovakia
  • BRATISLAVA
Slovenia
  • LJUBLJANA
Taiwan
  • TAIPEI
Venezuela
  • CARACAS

Link to trial result

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