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

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:

  1. Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
  2. 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
  3. 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

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84 participants in 2 patient groups

Entecavir (0.5 mg)

Experimental group

Treatment:

Drug: Entecavir

Entecavir (1mg)

Experimental group

Treatment:

Drug: Entecavir