NCT00124241

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

First QC Date

July 25, 2005

Last Update Submit

May 8, 2015

Conditions

Hepatitis B

Interventions

telbivudineDRUG
lamivudineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patient is pregnant or breast-feeding
  • Patient has signs of decompensated chronic hepatitis B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Toronto, Canada

Location

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Paris, France

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

TelbivudineLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDeoxycytidineCytidineDideoxynucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Primary Completion

February 1, 2003

Study Completion

November 1, 2005

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

US(1)FR(1)CA(1)CN(1)