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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

NCT02598063 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2016-02-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • China
  • Hong Kong

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598063 on ClinicalTrials.gov