Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037166
AI463-052

Details and patient eligibility

About

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy

Enrollment

84 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documentation of chronic hepatitis B infection by ALL of the following:

  • Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
  • Patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented YMDD mutation or other lamivudine-resistant mutation while on lamivudine
  • Documented HBV Viremia ≥ 10*5: copies/mL
  • ALT in the range of 1.3 to 10 x ULN
  • Subjects must have well-compensated liver disease a) value

Exclusion criteria

-

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups

Entecavir (0.5 mg)
Experimental group
Treatment:
Drug: Entecavir
Entecavir (1mg)
Experimental group
Treatment:
Drug: Entecavir

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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