A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036608

AI463-026

Details and patient eligibility

About

The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of HBeAg-positive chronic hepatitis B infection;
• Incomplete response to current lamivudine therapy;
• HBeAg-positive;
• Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV);
• Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.