CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,470 enrolled
Drug / intervention
adefovir dipivoxildrug
Likely dose
adefovir dipivoxil 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00441974
NCT00441974Phase 4Completed
CompareCT.gov

A 48-week Multi-centre, Open-label, Local Phase IV Study to Demonstrate the Efficacy and Safety of Adefovir Dipivoxil Tablets (10mg) in Chinese Subjects With Compensated Chronic Hepatitis B

GlaxoSmithKline·interventional·Posted Mar 1, 2007·Updated Oct 20, 2009

In Brief

A Phase 4 clinical trial evaluating adefovir dipivoxil for Chronic Hepatitis B. Completed, enrolled 1,470 participants across 25 sites.

Detailed Summary

This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB. Primary endpoint is proportion of subjects achieving HBV DNA undetectable (\<=1000 copies/mL by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be recruited in 30 study centers in China. The subjects are offered 48 weeks of open label adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week post study treatment follow-up prior to study completion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.3 years ago

Interventions

adefovir dipivoxildrug

adefovir dipivoxil once daily one tablet 10mg orally