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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: Completed Phase 3 study of HBeAg-negative Chronic Hepatitis B, sponsored by Gilead Sciences.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy endpoint was determined by the achievement of HBV DNA \< 29 IU/mL at Week 48.
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 |
What the finished NCT01940341 record still lists
NCT01940341 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01940341's enrollment target sits among peer trials
426 882nd of 2000 higher than 1,118 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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