CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Selgantolimod +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03491553
NCT03491553Phase 2Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Apr 9, 2018·Updated Aug 19, 2021

In Brief

A Phase 2 clinical trial evaluating Selgantolimod, Placebo, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 48 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesNew Zealand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 9, 2018
Enrollment StartApr 6, 2018
Primary CompletionMar 22, 2019
Study CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.2 years ago

Interventions

Selgantolimoddrug

Tablet(s) administered orally once weekly

Placebodrug

Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Hepatitis B virus (HBV) OAV Therapydrug

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®)