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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2013-09-12 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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