Clinical Trial Protocol Registry

Trial information

A Study of PEGASYS plus Ribavirin Combination Therapy in Patients with HBeAg-Negative Chronic Hepatitis B Infection

Status:
Completed
Protocol number:
HBV05
Company division:
Diagnostics
Official Scientific Title:
Peginterferon alfa-2a and ribavirin combination therapy in patients with HBeAg-negative chronic HBV infection (PARC Study)
Brief summary:
This study will investigate whether 48 weeks of combination therapy with PEGASYS and ribavirin enhances the virological and biochemical response, compared to PEGASYS monotherapy, in HbeAg-negative chronic hepatitis B patients.
Study type:
Interventional; Randomized; Parallel study
Conditions:
  • Hepatitis B, Chronic
Intervention type:
Diagnostic Test
Intervention name:
cobas TaqMan 48 HBV test
Inclusion criteria:
  • <LI>chronic hepatitis B, for > 6 months;
  • <LI>ALT >1.5x ULN;
  • <LI>HBeAg-negative, anti-HBeAg-positive.</LI>
Exclusion criteria:
  • <LI>antiviral treatment for hepatitis B in previous 6 months;
  • <LI>severe hepatitis, or advanced liver disease;
  • <LI>coinfection with HCV or HIV.</LI>
Gender:
Males or Females
Age limits:
Min: 18Years Max: 70Years
Accepts healthy volunteers:
No
Anticipated start date:
March, 2005
Trial registration date:
16.03.2006
Date last updated:
07.02.2008
This trial was conducted at the following locations:
Austria
  • Innsbruck
  • Vienna
France
  • TOULOUSE
Germany
  • Essen
  • Oberhausen
Greece
  • Athens
  • Thessaloniki
Italy
  • Catania
  • Messina
  • Palermo
Netherlands
  • Rotterdam
Norway
  • OSLO
Poland
  • Bialystok
  • Bydgoszcz
  • Poznan
  • Wroclaw
Romania
  • BAIA MARE
  • BUCHAREST
  • SUCEAVA
Turkey
  • Ankara
  • Istanbul

Link to trial result

For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.

  • Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.

Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.

For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)