Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor
NCT04023721 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2020-07-22
Summary
An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.
Conditions
- Hepatitis B
- HBV
- Hepatitis B, Chronic
Interventions
- DRUG
-
Inarigivir soproxil
Inarigivir soproxil 200 mg tablets
- DRUG
-
Nucleoside/nucleotide (NUC) analogue inhibitors
Continuation of prestudy NUC therapy
Sponsors & Collaborators
-
PRA Health Sciences
collaborator INDUSTRY -
F-star Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Don Mitchell · Spring Bank Pharmaceuticals
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
- 2019-06-18
- Primary Completion
- 2020-07-16
- Completion
- 2020-07-16
Countries
- Canada
- United Kingdom
Study Locations
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