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Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

NCT01940471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 875

Last updated 2023-10-10

Study results available
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Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

Conditions

  • HBeAg-positive Chronic Hepatitis B

Interventions

DRUG

TAF

25 mg tablet administered orally once daily

DRUG

TDF

300 mg tablet administered orally once daily

DRUG

TAF Placebo

Tablet administered orally once daily

DRUG

TDF Placebo

Tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-11
Primary Completion
2015-11-16
Completion
2022-10-13

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Hong Kong
  • India
  • Italy
  • Japan
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01940471 on ClinicalTrials.gov