Trials / Completed
CompletedNCT03491553
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selgantolimod | Tablet(s) administered orally once weekly |
| DRUG | Placebo | Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly |
| DRUG | Hepatitis B virus (HBV) OAV Therapy | Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®) |
Timeline
- Start date
- 2018-04-06
- Primary completion
- 2019-03-22
- Completion
- 2020-08-10
- First posted
- 2018-04-09
- Last updated
- 2021-08-19
- Results posted
- 2020-04-01
Locations
2 sites across 2 countries: United States, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03491553. Inclusion in this directory is not an endorsement.