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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01940471

Public ClinicalTrials.gov record NCT01940471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 12:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01940471
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
875 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 11, 2013 (Actual)
Primary completion
Nov 16, 2015 (Actual)
Completion
Oct 13, 2022 (Actual)
Last update posted
Oct 10, 2023

2013 – 2022

United States locations

U.S. sites
15
U.S. states
8
U.S. cities
13
Facility City State ZIP Site status
Coalition of Inclusive Medicine Los Angeles California 90020 —
Stanford University Medical Center Palo Alto California 94304 —
Huntington Medical Research Institutes Pasadena California 91105 —
Research and Education, Inc. San Diego California 92105 —
Silicon Valley Research Institute San Jose California 95128 —
University of Miami Miami Florida 33136 —
Digestive Disease Associates, PA Catonsville Maryland 21228 —
Tufts Medical Center, Inc Boston Massachusetts 02111 —
Henry Ford Health System Detroit Michigan 48202 —
Sing Chan Private Practice Flushing New York 11354 —
New Discovery, LLC Flushing New York 11355 —
Jefferson Medical College Philadelphia Pennsylvania 19107 —
Xiaoli Ma, PC Philadelphia Pennsylvania 19107 —
Texas Clinical Research Institute, LLC Arlington Texas 76012 —
Kelsey Research Foundation Houston Texas 77005 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 145 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01940471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 10, 2023 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01940471 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →