An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00124241

Enrollment

Unknown

Registered

2005-07-27

Start date

Unknown

Completion date

2005-11-30

Last updated

2015-05-12

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

Conditions

Hepatitis B

Brief summary

This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.

Interventions

DRUGtelbivudine

DRUGlamivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug * Patient remains seropositive for hepatitis B surface antigen (HBsAg) Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Patient is pregnant or breast-feeding * Patient has signs of decompensated chronic hepatitis B Other protocol-defined

Countries

Canada, China, France, United States

Outcome results

None listed

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