Trial Information

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

Status: No longer recruiting

Protocol Number: ML18376

Sponsor: Shanghai Roche Pharmaceuticals Ltd.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study evaluating the effect of peginterferon alfa-2a (40KD) PEGASYSŪ or adefovir dipivoxil (ADV) on HBeAg seroconversion in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B

Brief Summary: This study will evaluate the efficacy and safety of PEGASYS, or a comparator drug, in patients with lamivudine-resistant HBeAg-positive chronic HBV. Patients will be randomized to receive either PEGASYS for 48 weeks in combination with oral lamivudine for the first 12 weeks, or a comparator drug for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 244.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Hepatitis B, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at week 72.

Key Secondary Outcomes: 1. Loss of HBeAg; reduction in HBV DNA; ALT normalization; HbsAg seroconversion

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • HBsAg-positive, HBeAg-positive, and anti-HBs-negative for >=6 months;
  • receiving lamivudine currently, and for >=6 months;
  • HBV-DNA decreased >=2 log during lamivudine treatment on >=1 occasion;
  • absence of cirrhosis confirmed by liver biopsy in previous 6 months.

Exclusion Criteria:

  • other drugs with activity against HBV within the prior 6 months, except lamivudine;
  • antiviral, anti-neoplastic, or immunomodulatory therapy <=6 months before study;
  • active infection with hepatitis A, C, or D virus, or human immunodeficiency virus;
  • decompensated liver disease;
  • medical condition associated with another chronic liver disease.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2005

Trial Registration Date: 12/13/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Hong Kong, China, 852
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:49:47 PM


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