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Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)

NCT01300234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2018-07-13

Study results available
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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.

Conditions

Interventions

DRUG

Tenofovir disoproxil fumarate (TDF) tablets

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

DRUG

Adefovir dipivoxil (ADV) tablets

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-30
Primary Completion
2012-10-17
Completion
2016-12-06

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01300234 on ClinicalTrials.gov