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: Diagnostic
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
Condition: Hepatitis B, Chronic
Intervention type: Diagnostic Test
Intervention name: cobas TaqMan 48 HBV test
Inclusion criteria:
chronic hepatitis B, for > 6 months;
ALT >1.5x ULN;
HBeAg-negative, anti-HBeAg-positive.
Exclusion criteria:
antiviral treatment for hepatitis B in previous 6 months;
severe hepatitis, or advanced liver disease;
coinfection with HCV or HIV.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2005
Trial registration date: 03/16/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Germany
Greece
Italy
- Augusta
- Catania
- Galatina
- Messina
- Palermo
Netherlands
Poland
- Bialystok
- Bydgoszcz
- Krakow
- Poznan
- Wroclaw
Turkey
