Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

PHASE3CompletedINTERVENTIONAL
Enrollment

1,869

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Chronic Hepatitis B
Interventions
DRUG

Telbivudine (LdT)

Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.

Trial Locations (39)

3084

Novartis Investigational Site, Heidelberg

10029

Novartis Investigational Site, New York

19103

Novartis Investigational Site, Philadelphia

23220

Novartis Investigational Site, Richmond

30159

Novartis Investigational Site, Hanover

48104

Novartis Investigational Site, Ann Arbor

60176

Novartis Investigational Site, Chicago

63143

Novartis Investigational Site, St Louis

75270

Novartis Investigational Site, Paris

77007

Novartis Investigational Site, Houston

85001

Novartis Investigational Site, Phoenix

90001

Novartis Investigational Site, Los Angeles

90073

Novartis Investigational Site, Los Angeles

91103

Novartis Investigational Site, Pasadena

91945

Novartis Investigational Site, San Diego

94115

Novartis Investigational Site, San Francisco

96812

Novartis Investigational Site, Honolulu

999077

Novartis Investigational Site, Hong Kong

1613101

Novartis Investigational Site, Nazareth

Unknown

Novartis Investigational Site, Sacramento

Novartis Investigational Site, Sarasota

Novartis Investigational Site, Atlanta

Novartis Investigational Site, Toronto

Novartis Investigational Site, Beijing

Novartis Investigational Site, Prague

Novartis Investigational Site, New Delhi

Novartis Investigational Site, Torino

Novartis Investigational Site, Hamilton

Novartis Investigational Site, Krakow

Novartis Investigational Site, Santurce

Novartis Investigational Site, Singapore

Novartis Investigational Site, Seoul

Novartis Investigational Site, Valencia

Novartis Investigational Site, Tainan City

Novartis Investigational Site, Bangkok

Novartis Investigational Site, London

02215

Novartis Investigational Site, Boston

27599-7211

Novartis Investigational Site, Chapel Hill

TR-34353

Novartis Investigational Site, Istanbul

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY