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Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

NCT00076336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2011-09-05

Study results available
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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.

Conditions

  • Hepatitis
  • Hepatitis B, Chronic
  • Cirrhosis

Interventions

DRUG

Telbivudine

600mg/day oral tablet for 104 weeks

DRUG

Lamivudine

100mg/day oral tablet for 104 weeks

DRUG

Placebo

Telbivudine matching placebo or lamivudine matching placebo tablet.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2009-12-31

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • India
  • Israel
  • Latvia
  • Malaysia
  • New Zealand
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076336 on ClinicalTrials.gov