Trial Information
Summary: A Study of PEGASYS plus Ribavirin Combination Therapy in Patients with HBeAg-Negative Chronic Hepatitis B Infection
Status: Completed
Protocol Number: HBV05
Sponsor:
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 Phase: N/A
Study Design / Study Details:
- Purpose:
- Allocation: Randomized
- Masking:
- Control:
- Assignment: Parallel
- Endpoints:
Study Type:
Interventional
Condition: Hepatitis B, Chronic
Intervention Type: Diagnostic Test
Intervention Name: cobas TaqMan 48 HBV test
Primary Outcome:
Key Secondary Outcomes:
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: 02/07/2008
Link To Trial Results
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Contact:
Research Site:
Located In:
Innsbruck, Austria,
Telephone: 973-235-5000 or 800-526-6367
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Trial listings updated: August 20, 2008 at 2:16:32 PM