NCT00376259

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	telbivudine	600mg/day oral tablet for 96 weeks
DRUG	adefovir dipivoxil	10 mg of adefovir by mouth once daily

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-08-01
• First posted: 2006-09-14
• Last updated: 2011-06-30
• Results posted: 2011-05-17

Locations

6 sites across 5 countries: United States, Hong Kong, South Korea, Taiwan, Thailand