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Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

NCT00410072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2013-03-15

Study results available
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Summary

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks

DRUG

Entecavir + Tenofovir

Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, 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
2007-04-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • France
  • India
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Africa
  • 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 NCT00410072 on ClinicalTrials.gov