Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00095121
Status:
COMPLETED
Last Update Posted:
2012-05-22
First Post:
2004-10-29
Brief Title:
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents Age 2 to Less Than 18 With Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents age 2 to less than 18 years following 48 weeks of placebo-controlled double-blind treatment and following an additional 192 weeks of open-label adefovir dipivoxil treatment
Detailed Description:
Weeks 1 through 48 Study Year 1 The first 48 weeks of the study were a randomized double-blind placebo-controlled parallel-group treatment period Participants were randomly assigned to treatment in a 21 fashion to ADV or PLB Prior to randomization eligible participants were classified into 1 of 6 strata based upon age at screening 2 to 7 years 7 to 12 years 12 to 18 years and prior exposure to treatment for chronic hepatitis B CHB prior treatment no prior treatment
Weeks 49 through 240 Study Years 2 through 5 At Week 48 all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen HBsAg seroconversion at Week 44 plus all ADV-treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks Any participant with HBV DNA 1000 copiesmL at 2 consecutive visits 12 weeks apart was to be discontinued from open-label study treatment The only exception was for participants in the adolescent age range with prior lamivudine experience who were allowed the opportunity to add lamivudine to ADV similarly if combination failed to impart suppression of HBV DNA below 1000 copiesmL confirmed discontinuation was necessary All participants who discontinued study drug due to confirmed seroconversion were requested to continue to return for study visits for the remainder of the study in order to evaluate the durability of seroconversion Participants who wished to discontinue study treatment and withdraw from the study prior to study completion were requested to return every 4 weeks for 16 weeks for posttreatment evaluations following an early termination visit Any participants who experienced posttreatment hepatic flares during the 16-week follow-up period were to be followed every 4 weeks until their ALT levels returned to 2 times the upper limit of normal ULN for a maximum off-treatment follow-up of 6 months Participants who experienced a severe hepatic flare per protocol definition after discontinuation of ADV during the open-label treatment period may have been eligible to receive ADV for treatment of the hepatic flare after consultation with the Gilead medical monitor
Weeks 49 through 240 Study Years 2 through 5 At Week 48 all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen HBsAg seroconversion at Week 44 plus all ADV-treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks Any participant with HBV DNA 1000 copiesmL at 2 consecutive visits 12 weeks apart was to be discontinued from open-label study treatment The only exception was for participants in the adolescent age range with prior lamivudine experience who were allowed the opportunity to add lamivudine to ADV similarly if combination failed to impart suppression of HBV DNA below 1000 copiesmL confirmed discontinuation was necessary All participants who discontinued study drug due to confirmed seroconversion were requested to continue to return for study visits for the remainder of the study in order to evaluate the durability of seroconversion Participants who wished to discontinue study treatment and withdraw from the study prior to study completion were requested to return every 4 weeks for 16 weeks for posttreatment evaluations following an early termination visit Any participants who experienced posttreatment hepatic flares during the 16-week follow-up period were to be followed every 4 weeks until their ALT levels returned to 2 times the upper limit of normal ULN for a maximum off-treatment follow-up of 6 months Participants who experienced a severe hepatic flare per protocol definition after discontinuation of ADV during the open-label treatment period may have been eligible to receive ADV for treatment of the hepatic flare after consultation with the Gilead medical monitor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None