A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

PHASE4CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

December 31, 2011

Conditions
Hepatitis B, Chronic
Interventions
DRUG

Tenofovir

All patients receive 600 mg/day, oral telbivudine for 24 weeks. Patients with non-detectable HBV DNA continue 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 1) Patients with detectable HBV DNA receive 300 mg/day, oral tenofovir plus 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 2)

Trial Locations (4)

Unknown

Novartis, Buenos Aires

Novartis, São Paulo

Novartis, Frankfurt

Novartis, Bangkok

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY