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Antiviral Efficacy of Switching to ETV Plus TDF

NCT01597934 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-01-31

No results posted yet for this study

Summary

Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result in faster and greater antiviral activity and lower rates of resistance emergence over maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders to LAM/LdT+ADV rescue therapy.

Earlier switching to combination with the most potent regimen will be more effective to achieve virologic response(VR) and prevent further resistance emergence.

All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be assessed at baseline and every three months thereafter. Evaluations at each visit will include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse events. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.

Conditions

Interventions

DRUG

Group A (Zeffix, Sebivo, Hepsera)

Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg

DRUG

Group B (Baraclude, Viread)

Switching to ETV plus TDF combination Entecavir 1.0mg + Tenofovir 300mg

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    collaborator OTHER

  • The Catholic University of Korea

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • Pusan National University Hospital

    collaborator OTHER

  • Kyungpook National University Hospital

    collaborator OTHER

  • Hallym University Medical Center

    collaborator OTHER

  • Chonbuk National University Hospital

    collaborator OTHER

  • Yonsei University

    lead OTHER

Principal Investigators

  • Sang Hoon Ahn, MD, PhD · Yonsei University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

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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 NCT01597934 on ClinicalTrials.gov