A Phase II Dose Response Study in Japan in Chronic Hepatitis B

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022801

AI463-047

Details and patient eligibility

About

To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy,
• Positive for HBeAg OR negative for HBeAg with positive HBeAb,
• Documented HBV Viremia on 2 or more occasions: Viremia on sample drawn AND HBV DNA of ≥ 40 MEq/mL by Quantiplex assay at the screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Entecavir (0.01 mg)

Experimental group

Treatment:

Drug: Entecavir

Entecavir (0.1 mg)

Experimental group

Treatment:

Drug: Entecavir

Entecavir (0.5 mg)

Experimental group

Treatment:

Drug: Entecavir