CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 512 enrolled
Drug / intervention
Tenofovir disoproxil fumarate (TDF) tablets +1 moredrug
Likely dose
Tenofovir disoproxil fumarate (TDF) tablets 300mgfrom 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/NCT01300234
NCT01300234Phase 3Completed
CompareCT.gov

A Multi-centre, Double Blind, Double Dummy, Randomised, Controlled Study to Evaluate the Efficacy and Safety of TDF 300mg Once Daily (QD) Versus Adefovir Dipivoxil (ADV) 10mg QD in Chinese Subjects With CHB

GlaxoSmithKline·interventional·Posted Feb 21, 2011·Updated Jul 13, 2018

In Brief

A Phase 3 clinical trial evaluating Tenofovir disoproxil fumarate (TDF) tablets and Adefovir dipivoxil (ADV) tablets for Hepatitis B. Completed, enrolled 512 participants across 20 sites.

Detailed Summary

This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen \[HBeAg\] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartMar 30, 2011
Primary CompletionOct 17, 2012
Study CompletionDec 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.4 years ago

Interventions

Tenofovir disoproxil fumarate (TDF) tabletsdrug

white, almond-shaped, film-coated tablets containing 300mg of TDF

Adefovir dipivoxil (ADV) tabletsdrug

white to off-white, round, biconvex tablets containing 10mg of ADV