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A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: Lamivudine Placebo
Drug: Lamivudine
Drug: Entecavir
Drug: Entecavir Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00393484
AI463-105

Details and patient eligibility

About

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Enrollment

122 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Nucleoside and nucleotide-naive subjects with chronic HBV infection
  • Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
  • Detectable HBsAg
  • HBV DNA ≥ 105 copies/mL by PCR
  • ALT 1.3 to 10 x the ULN
  • HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

122 participants in 2 patient groups

Arm A
Experimental group
Description:
Entecavir + Lamivudine placebo (0-96 weeks) Entecavir (96-240 weeks)
Treatment:
Drug: Lamivudine Placebo
Drug: Entecavir
Arm B
Active Comparator group
Description:
Lamivudine + Entecavir placebo (0-96 weeks) Lamivudine (96-240 weeks)
Treatment:
Drug: Entecavir Placebo
Drug: Lamivudine

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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