Trials / Completed
CompletedNCT03180619
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and/or Hepatic Impairment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAF | Tablet administered orally once daily |
Timeline
- Start date
- 2017-06-29
- Primary completion
- 2019-03-27
- Completion
- 2020-09-04
- First posted
- 2017-06-08
- Last updated
- 2021-09-27
- Results posted
- 2020-04-09
Locations
30 sites across 8 countries: United States, Canada, Hong Kong, Italy, New Zealand, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03180619. Inclusion in this directory is not an endorsement.