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Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

NCT03434353 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-04-04

Study results available
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Summary

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

Conditions

Interventions

DRUG

Inarigivir Soproxil

Administered orally once daily one hour before or one hour after a meal

DRUG

TAF

Administered orally once daily with food

Sponsors & Collaborators

  • F-star Therapeutics, Inc.

    collaborator INDUSTRY

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2020-01-20
Completion
2021-01-26
FDA Drug
Yes

Countries

  • Hong Kong
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434353 on ClinicalTrials.gov