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NCT01940341 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of HBeAg-negative Chronic Hepatitis B, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
426
Enrollment target
20
Study locations

NCT01940341 is a Phase 3 study of HBeAg-negative Chronic Hepatitis B that has completed, run by Gilead Sciences. The registered enrollment target is 426 participants. The trial reports 20 study locations across 11 states.

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The verdict

NCT01940341, a Phase 3 study of HBeAg-negative Chronic Hepatitis B, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
426 participants
Enrollment target
20
Study locations

Study 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)-negative chronic hepatitis B virus (HBV) infection.

Interventions

  • DRUG TAF
  • DRUG TDF
  • DRUG TDF Placebo
  • DRUG TAF Placebo

Study Locations (20)

California

  • Asian Pacific Liver Center - Los Angeles
  • Stanford University Medical Center - Palo Alto
  • Huntington Medical Research Institutes - Pasadena
  • Research and Education, Inc. - San Diego
  • University California San Francisco (UCSF) - San Francisco
  • Silicon Valley Research Institute - San Jose

Victoria

  • Monash Medical Centre - Clayton
  • St. Vincent's Hospital - Fitzroy
  • Royal Melbourne Hospital - Parkville

New York

  • Sing Chan Private Practice - Flushing
  • New Discovery, LLC - Flushing

Western Australia

  • Sir Charles Gairdner Hospital - Nedlands
  • Royal Perth Hospital - Perth

Florida

  • University of Miami - Miami

Maryland

  • Digestive Disease Associates, PA - Catonsville

Michigan

  • Henry Ford Health System - Detroit

New Jersey

  • ID Care - Hillsborough

Trial Details

FieldValue
Enrollment Target 426 participants
Start Date 2013-09-12
Est. Completion 2022-08-31
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01940341

The ClinicalTrials.gov registry entry for NCT01940341 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 426 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HBeAg-negative Chronic Hepatitis B appearing as the primary indexed condition, and to 4 interventions - of which TAF is the first listed.

NCT01940341 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Victoria, New York.

Frequently Asked Questions

What is clinical trial NCT01940341 about?

NCT01940341 is a clinical study titled "Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen". 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)-negative chronic hepatitis B virus (HBV) infection...

What is the current status of trial NCT01940341?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2013-09-12. Estimated completion is 2022-08-31.

What conditions does trial NCT01940341 study?

This clinical trial studies the following conditions: HBeAg-negative Chronic Hepatitis B.

What interventions are being tested in trial NCT01940341?

The interventions under investigation include: TAF (DRUG), TDF (DRUG), TDF Placebo (DRUG), TAF Placebo (DRUG).

Who is sponsoring clinical trial NCT01940341?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01940341 being conducted?

This trial has 20 study locations across California, Florida, Maryland, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.