Clinical Trial: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Brief Summary: This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

• Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL [ Time Frame: Week 96 ]
  This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.
• Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL [ Time Frame: Week 96 ]
  This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.

Original Primary Outcome: HBeAg positive patients: HBV DNA <100,000 copies/mL at end of follow-up. HBeAg negative patients: HBV DNA <20,000 copies/mL at end of follow-up.

Current Secondary Outcome:

• Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion [ Time Frame: Week 96 ]
  Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.
• Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT [ Time Frame: Week 96 ]
  Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.
• Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ]
  All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.
• Mean Change in Laboratory Parameters (ALT Levels) [ Time Frame: From Screening (Day 0) to Week 96 ]
  Mean Change in Laboratory parameters (ALT levels) is reported.

Original Secondary Outcome: Efficacy: HBV DNA <400 copies/mL; HBsAg seroconversion; ALT normalisation; sustained HBe seroconversion in HBeAg positive patients. Safety: AEs, lab parameters.

Information By: Hoffmann-La Roche

Dates:
Date Received: June 18, 2007
Date Started: August 2006
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017