NCT02598063

A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Adefovir dipivoxil	ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
DRUG	Lamivudine	Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
DRUG	Peginterferon alfa-2a	Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2015-11-05
• Last updated: 2016-02-02

Locations

12 sites across 2 countries: China, Hong Kong