53
Participants
Start Date
October 31, 2014
Primary Completion Date
January 9, 2019
Study Completion Date
January 9, 2019
Telbivudine
Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
Placebo
Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily
Novartis Investigative Site, Sofia
Novartis Investigative Site, Sofia
Novartis Investigative Site, Pleven
Novartis Investigative Site, Varna
Novartis Investigative Site, Athens
Novartis Investigative Site, Nazareth
Novartis Investigative Site, Diyarbakır
Novartis Investigative Site, Vinnytsia
Novartis Investigative Site, Nahariya
Novartis Investigative Site, Elâzığ
Novartis Investigative Site, Eskişehir
Novartis Investigative Site, Mersin
Novartis Investigative Site, Dnipropetrovsk
Novartis Investigative Site, Odesa
Novartis Investigative Site, Jerusalem
Novartis Investigative Site, Jerusalem
Novartis Investigative Site, Craiova
Novartis Investigative Site, Timișoara
Novartis Investigative Site, Cluj-Napoca
Novartis Investigative Site, Iași
Novartis Investigative Site, Goudi-Athens
Novartis Investigative Site, Bucharest
Novartis Investigative Site, Bucharest
Novartis Investigative Site, Bucharest
Novartis Investigative Site, Seoul
Novartis Investigative Site, Ankara
Novartis Investigative Site, Antalya
Novartis Investigative Site, Kiev
Novartis Investigative Site, Kyiv
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY