CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 232 enrolled
Drug / intervention
Telbivudine +2 moredrug
Likely dose
Telbivudine 600 mg orally once daily or Lamivudine 100 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Documented decompensated chronic hepatitis B with clinical history compatible with cirrhosis
  • ✓Child-Turcotte-Pugh score > 7 points
  • ✓Evidence of hepatic cirrhosis or portal hypertension
Key exclusion· 4
  • ✕Pregnant or breastfeeding
  • ✕Coinfection with hepatitis C (HCV), hepatitis D (HDV), or HIV
  • ✕Prior receipt of lamivudine, adefovir, or investigational anti-HBV nucleoside/nucleotide analog at any time
  • ✕Interferon or other immunomodulatory treatment for HBV within 12 months before screening

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

Search/NCT00076336
NCT00076336Phase 3Completed
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Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

Novartis Pharmaceuticals·interventional·Posted Jan 22, 2004·Updated Sep 5, 2011

In Brief

A Phase 3 clinical trial evaluating Telbivudine, Lamivudine, and 1 other intervention for Hepatitis and 2 related conditions. Completed, enrolled 232 participants across 28 sites in 21 countries.

Detailed Summary

This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis, Hepatitis B, Chronic, Cirrhosis
CountriesAustralia, Canada, China, France, Germany, India, Israel, Latvia, Malaysia, New Zealand, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2004
Enrollment StartDec 1, 2003
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 22.4 years ago

Interventions

Telbivudinedrug

600mg/day oral tablet for 104 weeks

Lamivudinedrug

100mg/day oral tablet for 104 weeks

Placebodrug

Telbivudine matching placebo or lamivudine matching placebo tablet.