A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2018

Conditions
Chronic Hepatitis B Virus, Pediatric
Interventions
DRUG

Entecavir

Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response

DRUG

Placebo

Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response

Trial Locations (44)

100

Local Institution, Taipei

704

Local Institution, Tainan City

1200

Local Institution, Brussels

1425

Local Institution, Bunos Aires

10029

Mount Sinai Medical Center, New York

13110

Local Institution, Safed

19104

Children'S Hospital Of Philadelphia, Philadelphia

20010

Children'S National Medical Center, Washington D.C.

21287

Johns Hopkins School Of Medicine, Baltimore

22031

Inova Fairfax Hospital For Children, Fairfax

28203

Levine Children'S Hospital At Carolinas Medical Center, Charlotte

30322

Romero, Rene, Atlanta

32610

University Of Florida, Gainesville

42283

Local Institution, Wuppertal

46202

Indiana University School Of Medicine / Riley Hospital, Indianapolis

54635

Local Institution, Thesaloniki

55131

Local Institution, Mainz

77030

Texas Children'S Hospital, Houston

82319

Local Institution, Starnberg

84101

Local Institution, Beersheba

94143

University Of California, San Francisco, San Francisco

111123

Local Institution, Moscow

117198

Local Institution, Moscow

197022

Local Institution, Saint Petersburg

300011

Local Institution, Timișoara

500029

Local Institution, Hyderabad

654063

Local Institution, Novokuznetsk

700309

Local Institution, Iași

781006

Local Institution, Guwahati

06106

Connecticut Children'S Medical Center, Hartford

02114

Shah, Uzma, Boston

02115

Boston Childrens Hospital, Boston

02903

Rhode Island Hospital, Providence

M5G 1X8

Local Institution, Toronto

Unknown

Local Institution, Petah Tikva

85-030

Local Institution, Bydgoszcz

31-202

Local Institution, Krakow

50-345

Local Institution, Wroclaw

011743

Local Institution, Bucharest

700-721

Local Institution, Daegu

135-710

Local Institution, Seoul

138-736

Local Institution, Seoul

SE5 9RS

Local Institution, London

B4 6NH

Local Institution, Birmingham

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT01079806 - A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection | Biotech Hunter | Biotech Hunter