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Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection

NCT01594905 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-01-31

No results posted yet for this study

Summary

Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective antiviral activity and prevent further development of antiviral resistance in hepatitis B e antigen(HBeAg)-positive or -negative Chronic Hepatitis B(CHB) patients who experienced multidrug resistance

All subjects will orally take investigational drugs once daily for 48 weeks. All subjects will be assessed at baseline, Week 4, 12, 24, 36 and 48. Evaluations at each visit will include vital signs, physical examinations, laboratory tests and HBV DNA levels. They were also questioned about adverse events and concomitant medications. 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

Entecavir + Tenofovir (MDR group)

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

  • Yonsei University

    lead OTHER

Principal Investigators

  • Sang Hoon Ahn, MD, PhD · Yonsei University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

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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 NCT01594905 on ClinicalTrials.gov