Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Disease; Hepatitis B

Treatments: Drug: adefovir; Drug: entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00096785

AI463-079

Details and patient eligibility

About

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Enrollment: 69 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Chronic hepatitis B treatment naive
• Compensated liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

A1

Active Comparator group

Treatment:

Drug: entecavir

A2

Active Comparator group

Treatment:

Drug: adefovir