Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B

PHASE3CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

May 31, 2006

Study Completion Date

April 30, 2010

Conditions
Chronic Hepatitis B
Interventions
DRUG

Placebo (PLB)

Matching placebo

DRUG

Adefovir Dipivoxil (ADV)

10-mg tablet or 2-mg/mL oral suspension

DRUG

Lamivudine

100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained \>= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.

Trial Locations (1)

Unknown

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY