drugset / Trial / NCT00376259

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

NCT00376259 ↗

Phase 3 Terminated 43 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Timeline

Start
2007-01
Primary completion
2008-08
Completion
—

Outcome

Outcome not reported

Stopped: “The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA)”

Drugs

EvaluationDrugModalityDoseRoute
Subject Adefovir dipivoxil Small molecule 10 mg Oral
Subject Telbivudine Small molecule 600 mg Oral