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Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

NCT00410202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2013-11-21

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

Tablets, Oral, 1mg, once daily, 100 weeks

DRUG

Tenofovir

Tablets, Oral, 300 mg, once daily

DRUG

Adefovir

Tablets, Oral, 10mg, once daily, 100 weeks

DRUG

Lamivudine

Tablets, Oral, 100mg, once daily, 100 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-01-31
Completion
2012-07-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Greece
  • Hong Kong
  • India
  • Indonesia
  • Italy
  • Malaysia
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

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 NCT00410202 on ClinicalTrials.gov