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Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

NCT01063036 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2014-12-15

Study results available
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Summary

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Conditions

Interventions

DRUG

Entecavir

Tablets, Oral, 1 mg, once daily, 96 weeks

DRUG

Tenofovir

Tablets, Oral, 300 mg, once daily, 96 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2014-02-28

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT01063036 on ClinicalTrials.gov