Trials / Completed
CompletedNCT01940471
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 875 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study GS-US-320-0110 is a multi-center clinical trial planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort are registered separately (NCT02836249) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-09-11
- Primary completion
- 2015-11-16
- Completion
- 2022-10-13
- First posted
- 2013-09-12
- Last updated
- 2023-10-10
- Results posted
- 2017-03-30
Locations
160 sites across 19 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
Source: ClinicalTrials.gov record NCT01940471. Inclusion in this directory is not an endorsement.