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

    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


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