CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,869 enrolled
Drug / intervention
Telbivudine (LdT)drug
Likely dose
Telbivudine 600 mg orally once dailyAI-extracted
Key inclusion· 2
  • ✓Completed a previous qualifying Idenix-sponsored telbivudine trial
  • ✓Not discontinued from the prior Idenix-sponsored study
Key exclusion· 2
  • ✕Pregnant or breastfeeding
  • ✕Co-infected with hepatitis C, hepatitis D, or HIV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00142298
NCT00142298Phase 3Completed
CompareCT.gov

An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies

Novartis Pharmaceuticals·interventional·Posted Sep 2, 2005·Updated Aug 21, 2020

In Brief

A Phase 3 clinical trial evaluating Telbivudine (LdT) for Chronic Hepatitis B. Completed, enrolled 1,869 participants across 39 sites in 21 countries.

Detailed Summary

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesAustralia, Canada, China, Czechia, France, Germany, Hong Kong, India, Israel, Italy, New Zealand, Poland, Puerto Rico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartMar 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago

Interventions

Telbivudine (LdT)drug

Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.