Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection
Status:
Unknown status
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Yonsei University
Collaborators:
Bristol-Myers Squibb Seoul St. Mary's Hospital The Catholic University of Korea