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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036608

Enrollment

Unknown

Registered

2002-05-13

Start date

2002-01-31

Completion date

2005-02-28

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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.

Interventions

DRUGEntecavir

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026