Entecavir Plus Adefovir in Lamivudine-Resistant Patients

NCT00986778 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-09-01

No results posted yet for this study

Summary

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Lamivudine

Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response

DRUG

Entecavir

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

DRUG

Adefovir

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

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
2009-12-31
Primary Completion
2012-12-31
Completion
2014-06-30

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Entities

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 NCT00986778 on ClinicalTrials.gov