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Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients

A Phase 2, Open-label Study Evaluating the Intra-hepatic Effect of Inarigivir 400 mg Per Day and 400 mg Three Times Per Week on Immune Response and Viral Markers in Virally Suppressed Patients With Chronic Hepatitis B Infection

NCT03932513•F-star Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection

Detailed Description

This is a single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection

Eligibility

Age

21 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged ≥ 21 to ≤ 70 years
•2. Chronic hepatitis B infection defined as HBsAg positive and on NUC therapy for at least one year.
•1. Have at least one prior documented result of HBV DNA ≤ 20 IU/mL LLOQ from a local laboratory, 6 or more months prior to Screening
•2. HBV DNA ≤ 20 IU/mL at Screening tested by the Central Laboratory
•3. Have been on a commercially available HBV oral antiviral (OAV) treatment(s) (tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening.
•3. Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months of randomization date with no evidence of hepatocellular carcinoma
•4. Must be willing and able to comply with all study requirements including two liver biopsies
•5. Negative urine or serum pregnancy test (for women of childbearing potential documented within the 24-hour period prior to the first dose of test drug. If the urine pregnancy test is positive, a follow-up serum test is required for confirmation. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion. All fertile males must also refrain from sperm donation while on Active drug and for 3 months after completion of Active drug.
•6. Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures

Exclusion Criteria

•1. Any liver biopsy evidence of metavir F3 or F4 disease on any prior biopsy
•2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
•3. Evidence of advanced fibrosis at screening as defined by Fibroscan at the Screening Visit of ≥ 8 kilopascals
•4. Laboratory parameters not within defined thresholds: ALT or AST ≥ 40 IU, white blood cells \< 4500 cells/μL (SI unit \< 4.5 × 109/L), hemoglobin (HgB) \< 12 g/dL (SI unit \< 120 g/L) for females, \< 13 g/dL (SI unit \< 130 g/L) for males, platelets \< 150,000 per μL (SI unit \< 150 × 109/L), albumin \< 3.5 g/dL (SI unit \< 35 g/L), international normalized ratio (INR) \> 1.5, total bilirubin \> 1.2 mg/dL (SI unit \> 20.52 μmol/L), or alpha-fetoprotein (AFP) \> 50 ng/mL (SI unit \> 180.25 nmol/L). Patients with an elevated indirect bilirubin and known Gilbert's disease can be included if direct bilirubin is within normal limits. Patients with an AFP \> 50 ng/mL but ˂ 500 ng/mL can be included if computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months shows no evidence of hepatocellular carcinoma.
•5. Creatinine \> 1.2 mg/dL (SI unit \> 106.08 μmol/L), creatinine clearance \< 50 mL/min (SI unit \< 0.83 L/s/m2)
•6. Co-infection with hepatitis C virus, human immunodeficiency virus, or hepatitis D virus
•7. Evidence or history of hepatocellular carcinoma
•9. Significant cardiovascular, pulmonary, or neurological disease
•10. Received solid organ or bone marrow transplant
•11. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal antibody, Interferon)
+7 more criteria

Locations (1)

National University Hospital

Singapore, Singapore

Key Dates

Start Date

April 11, 2019

Primary Completion Date

December 21, 2019

Completion Date

December 21, 2019

Last Updated

April 29, 2020

Enrollment

ACTUAL participants

Conditions

HBVHepatitis BHepatitis B, Chronic

Interventions

inarigivir soproxil

DRUG

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

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RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series