AzTrials
AzTrials

HBVPhase 2NCT03932513

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

A Phase 2 study testing inarigivir soproxil in people with HBV and Hepatitis B, run by F-star Therapeutics, Inc. at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
HBV, Hepatitis B, Hepatitis B, Chronic
What is being tested?
inarigivir soproxil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSingapore
Study dates
11 Apr 2019to 21 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥ 21 to ≤ 70 years
  • Chronic hepatitis B infection defined as HBsAg positive and on NUC therapy for at least one year.
  • 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
  • HBV DNA ≤ 20 IU/mL at Screening tested by the Central Laboratory
  • 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.
  • Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months of randomization date with no evidence of hepatocellular carcinoma
Show all 9Show fewer
  • Must be willing and able to comply with all study requirements including two liver biopsies
  • 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.
  • Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures

Who cannot join

  • Any liver biopsy evidence of metavir F3 or F4 disease on any prior biopsy
  • Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
  • Evidence of advanced fibrosis at screening as defined by Fibroscan at the Screening Visit of ≥ 8 kilopascals
  • 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.
  • Creatinine > 1.2 mg/dL (SI unit > 106.08 μmol/L), creatinine clearance < 50 mL/min (SI unit < 0.83 L/s/m2)
  • Co-infection with hepatitis C virus, human immunodeficiency virus, or hepatitis D virus
Show all 18Show fewer
  • Evidence or history of hepatocellular carcinoma
  • Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Patients under evaluation for possible malignancy are not eligible.
  • Significant cardiovascular, pulmonary, or neurological disease
  • Received solid organ or bone marrow transplant
  • Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal antibody, Interferon)
  • Patients currently taking medication(s) that are transported through organic anion transporting polypeptide 1 including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
  • Use of any herbal medications or supplements during the study period
  • Use of another investigational agent within 3 months of Screening
  • Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
  • Females who are pregnant or may wish to become pregnant during the study
  • If the Investigator believes the prospective patient will not be able to comply with the requirements of the protocol and complete the study
  • Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives or safety of the patients

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: 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

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

Read the 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

Being tested
inarigivir soproxil
Medical subject headings
Hepatitis B, Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inarigivir soproxilDrug

    Also called SB 9200

    Inarigivir 200mg and 400mg oral tablets, once daily

Study groups in NCT03932513
Study groupRoleWhat they receive
Treatment A: inarigivir soproxilExperimentalInarigivir 400 mg once per day for 6 weeks (2800mg/week).
Receives: Drug: inarigivir soproxil
Treatment B: inarigivir soproxilExperimentalInarigivir 400 mg three times per week for 6 weeks (1200mg/week).
Receives: Drug: inarigivir soproxil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intra-hepatic immune response

    Relative change from Baseline to Week 6 of intra-hepatic immune response (quantitative measurement of 500-600 genes using Nanostring technology) in hepatocytes and liver immune cells derived from the central immunology core biopsy

    Measured: 6 Weeks

  2. Change in intra-hepatic anti-viral response

    Relative change from Baseline to Week 6 of intra-hepatic anti-viral response (HBV DNA, HBV RNA, HBV core levels, cccDNA and HBsAg levels) using PCR assays in hepatocytes and liver immune cells derived from the intra-hepatic virology biopsy.

    Measured: 6 Weeks

Secondary outcomes (8)

  1. Proportion of patients with an adverse event (AE), or a clinically significant clinical laboratory abnormality

    Proportion of patients during the Baseline to Week 6 inarigivir treatment period with an adverse event (AE), or a clinically significant clinical laboratory abnormality

    Measured: 6 weeks

  2. Correlation of change of intra-hepatic immune markers, serum cytokines and PBMC activation

    Correlation of change from Baseline to Week 6 of intra-hepatic immune markers, serum cytokines and PBMC activation measured by interferon-stimulated gene (ISG) production

    Measured: 6 weeks

  3. Correlation of change of intra-hepatic antiviral response and serum anti-viral response

    Correlation of change from Baseline to Week 6 of intra-hepatic antiviral response and serum anti-viral response

    Measured: 6 weeks

  4. Comparison of change of intra-hepatic biomarkers of immune activation

    Comparison of change in mRNA expression using Nanostring Technology, from Baseline to Week 6 of intra-hepatic biomarkers of immune activation between inarigivir 400 mg per day and 400 mg three times per week

    Measured: 6 weeks

  5. Comparison of change of peripheral biomarkers of immune activation

    Comparison of change in mRNA expression using Nanostring Technology, from Baseline to Week 6 of intra-hepatic and peripheral biomarkers of immune activation and anti-viral response between inarigivir 400 mg per day and 400 mg three times per week

    Measured: 6 weeks

  6. Comparison of change of anti-viral response

    Comparison of change in mRNA expression using Nanostring Technology, from Baseline to Week 6 of anti-viral response between inarigivir 400 mg per day and 400 mg three times per week

    Measured: 6 weeks

  7. Characterization of hepatic immune cells

    Characterization by immuno-phenotyping of hepatic immune cells at Baseline and Week 6. Hepatic immune cells are analyzed and sorted by phenotype using markers of cell activation status through flow cytometry.

    Measured: 6 weeks

  8. Characterization of exhaustion markers

    Characterization by immuno-phenotyping of exhaustion markers at Baseline and Week 6. Hepatic immune cells are analyzed and sorted by phenotype using markers T cell exhaustion through flow cytometry.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2019
  2. Study start11 Apr 2019
  3. Primary completion21 Dec 2019
  4. Study completion21 Dec 2019

Why it stopped: Study was halted due to suspected liver injury in another study with Inarigavir

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03932513
Sponsor's protocol ID
SBP-9200-HBV-203
Status last verified
Apr 2020
First submitted
22 Mar 2019
Last updated
29 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing inarigivir soproxil in people with HBV and Hepatitis B, run by F-star Therapeutics, Inc. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was halted due to suspected liver injury in another study with Inarigavir). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intra-hepatic immune response (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03932513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in