Trials / Completed
CompletedNCT02979613
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 490 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
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
- 2016-12-29
- Primary completion
- 2018-09-10
- Completion
- 2020-01-30
- First posted
- 2016-12-01
- Last updated
- 2020-09-14
- Results posted
- 2019-09-25
Locations
39 sites across 8 countries: United States, Canada, Hong Kong, Italy, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02979613. Inclusion in this directory is not an endorsement.