A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

PHASE3TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Chronic Hepatitis B
Interventions
DRUG

Entecavir + Tenofovir

Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks

DRUG

Adefovir + continuing Lamivudine

Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Trial Locations (29)

1200

Local Institution, Brussels

3000

Local Institution, Leuven

10025

Local Institution, New York

13353

Local Institution, Berlin

34093

Local Institution, Istanbul

34098

Local Institution, Istanbul

34360

Local Institution, Istanbul

34460

Local Institution, Istanbul

34722

Local Institution, Istanbul

35100

Local Institution, Izmir

35128

Local Institution, Padua

40237

Local Institution, Düsseldorf

41100

Local Institution, Modena

41380

Local Institution, Kocaeli

53105

Local Institution, Bonn

55131

Local Institution, Mainz

60612

Rush University Medical Center, Chicago

61080

Local Institution, Trabzon

71013

Local Institution, San Giovanni Rotondo

80135

Local Institution, Naples

90048

Cedars Sinai Medical Center, Los Angeles

94118

Kaiser Permanente Medical Center, San Francisco

98124

Local Institution, Messina

41-500

Local Institution, Chorzów

31-531

Local Institution, Krakow

20-089

Local Institution, Lublin

06010

Local Institution, Ankara

06620

Local Institution, Ankara

06100

Local Institution, Sihhiye Ankara

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00605384 - A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection | Biotech Hunter | Biotech Hunter