Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a(40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B Virus (HBV).

Status: Completed

Protocol Number: ML17700

Sponsor: Shanghai Roche Pharmaceuticals Ltd.

Company Division: Pharmaceutical

Official Scientific Title: Effect of peginterferon alfa-2a (40 KD) (PEGASYSŪ) on viral response in patients with HBeAg-positive chronic hepatitis B

Brief Summary: This is a study of the efficacy and safety of PEGASYS in naive, interferon- or lamivudine-pretreated patients with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Hepatitis B, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD)[PEGASYS]

Primary Outcome: 1. Efficacy: percentage of patients with HBV DNA <100,000 copies/mL at end of follow-up; percentage of patients with HBeAg seroconversion at end of follow-up.

Key Secondary Outcomes: 1. Efficacy: HBV DNA below limit of detection, HBeAg loss and seroconversion, ALT normalisation, combined response (HBV DNA, HBeAg loss, and ALT normalisation) at end of treatment and end of follow-up. Safety: AEs, laboratory parameters, vital signs.

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • HBeAg-positive chronic HBV;
  • treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

  • antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment;
  • co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV);
  • evidence of decompensated liver disease;
  • medical condition associated with chronic liver disease other than viral hepatitis.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 03/10/2006

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Shanghai, China, 200025
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:47:41 PM


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