CLINICAL TRIAL: A PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF

$1,957M01FY2010RRNIH

Children'S Research Institute, Washington DC

Investigators

Linked publications & trials

Paper 36608946 Paper 35642061 Paper 32900940 Paper 31764101 Paper 31115244 Paper 30556058 Paper 30529451 Paper 30169434 Paper 29454196 Paper 29377283 Paper 28291048 Paper 27364566 Paper 26885808 Paper 26717001 Paper 26696589 Paper 26573086 Paper 26484047 Paper 26421452 Paper 25942459 Paper 25940056 Paper 25794658 Paper 25738647 Paper 25714579 Paper 25599972 Paper 25535055 Paper 25516399 Paper 25492527 Paper 25356518 Paper 25082062 Paper 25066103 Paper 25000433 Paper 24969655 Paper 24945884 Paper 24941948 Paper 24921413 Paper 24777302 Paper 24739735 Paper 24565455 Paper 24535626 Paper 24044408 Paper 24038442 Paper 24002093 Paper 23838585 Paper 23787090 Paper 23690377 Paper 23686698 Paper 23667266 Paper 23625146 Paper 23595876 Paper 23493898 Paper 23472960 Paper 23450847 Paper 23439301 Paper 23406700 Paper 23392373 Paper 23349510 Paper 23293748 Paper 23265393 Paper 23255569 Paper 23245553 Paper 23149878 Paper 23033058 Paper 22933542 Paper 22926174 Paper 22820809 Paper 22771222 Paper 22611049 Paper 22573848 Paper 22563607 Paper 22525109 Paper 22521357 Paper 22479249 Paper 22461299 Paper 22402864 Paper 22383118 Paper 22343513 Paper 22267714 Paper 22244599 Paper 22213086 Paper 22197855 Paper 22174377 Paper 22116076 Paper 22110002 Paper 22050944 Paper 22036053 Paper 21999750 Paper 21979797 Paper 21953442 Paper 21941209 Paper 21876444 Paper 21856199 Paper 21802568 Paper 21760584 Paper 21753160 Paper 21743379 Paper 21698649 Paper 21681857 Paper 21674534 Paper 21613960 Paper 21612962

Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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 18) compared to placebo following 48 weeks of treatment;To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of treatment with adefovir dipivoxil or placebo;To evaluate the development of HBV mutants resistant to adefovir dipivoxil; To evaluate the long-term safety and efficacy in children and adolescents over an additional 4 year follow up period including assessment of growth and renal function. The common side effects were weakness, headache, stomach pain, nausea, gas, diarrhea, and upset stomach. some patients with advanced chronic hepatitis B liver disease and impaired kidney function, taking adefovir dipivoxil 10 mg caused nephrotoxicity. In children, complants of headache and dizziness were generally mild, and did not appear to be related to dose. The primary endpoint analysis will be performed when all patients reach the week 48 study visit. The adefovir dipivoxil treatment group will be compared to the placebo treatment group with respect to all efficacy endpoints. The intent to treat (ITT) population will be used for these analyses. The primary analysis will be performed on the intent-to-treat population.

View original record on NIH RePORTER →