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Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir

NCT01023217 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-02-10

Study results available
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Summary

The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV) and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who show suboptimal response to the combination of LAM and ADV.

In this randomized, open labeled trial,the investigators will compare the efficacy of continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and LAM.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Adefovir

Adefovir dipivoxil (Hepsera) 10 mg/day orally for 104 weeks

DRUG

Entecavir

Entecavir 1 mg/day orally

DRUG

Lamivudine

Lamivudine (Zeffix) 100 mg/day orally

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young-suk Lim, M.D.,Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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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 NCT01023217 on ClinicalTrials.gov