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Hepatitis BPhase 2NCT04059198

Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus

A Phase 2 study testing Inarigivir soproxil and Tenofovir alafenamide fumarate (TAF) in people with Hepatitis B and HBV, run by F-star Therapeutics, Inc. at 2 sites in Hong Kong.

Terminated

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

Official record
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Trial summary

An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B treatment-naive subjects with chronic HBV infection. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis B, HBV, Hepatitis B, Chronic
What is being tested?
Inarigivir soproxil and Tenofovir alafenamide fumarate (TAF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesHong Kong
Study dates
10 Oct 2019to 2 Apr 2020
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HBV-infected male and female subjects aged 18 to 70 years, inclusive
  • Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 6 months of enrollment date with no evidence of cirrhosis or hepatocellular carcinoma (HCC)
  • Must be willing and able to comply with all study requirements
  • Chronic HBV as defined by documented HBsAg or HBV DNA positive for 6 months or more
  • Not on any antiviral medications for at least 6 months. If a subject is hepatitis B e antigen (HBeAg)-negative, they will be eligible if they have not received antiviral medications for at least 3 months. Antiviral medications include lamivudine, telbivudine, adefovir, tenofovir, entecavir, IFN therapies of any type, and all other medications with potential antiviral activity.
  • HBV DNA >2000 IU/mL for HBeAg-negative subjects and >20,000 IU/mL for HBeAg-positive subjects at Screening
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  • ALT <5× ULN and ≤200 U/L
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of IP. If the urine pregnancy test is positive, a follow-up serum test is required for confirmation
  • Women of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 3 months after discontinuing study treatment. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception throughout the study and for 3 months after discontinuing study treatment. Male subjects must not donate sperm throughout the study and for 3 months after discontinuing study treatment.
  • Women of childbearing potential are sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (ie, who have not menstruated at all) for at least 1 year.
  • Highly effective methods of contraception are hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the subject. Note: The double-barrier method (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide only are not acceptable as highly effective methods of contraception.
  • Must have the ability to understand and sign a written informed consent form (ICF); consent must be obtained prior to initiation of study procedures

Who cannot join

  • Any prior liver biopsy evidence of metavir F3 or F4 disease
  • Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
  • Evidence of advanced fibrosis as defined by Fibroscan at the Screening Visit of ≥8 kPa. If Fibroscan is not available, subjects with both a Fibrotest ≥0.65 and aspartate transaminase (AST):platelet ratio index (APRI) ≥1.0 are excluded (subjects will not be excluded if only 1 of the Fibrotest or APRI results is higher than allowed)
  • Laboratory parameters not within defined thresholds:
  • White blood cells <4000 cells/μL (<4.0×109/L)
  • Hemoglobin <11 g/dL (<110 g/L) for females, <13 g/dL (<130 g/L) for males
Show all 23Show fewer
  • Platelets <130,000 per μL (<150×109/L)
  • Albumin <3.5 g/dL (<35 g/L)
  • International normalized ratio (INR) >1.5
  • Total bilirubin >1.2 mg/dL (>20.52 μmol/L) or alpha-fetoprotein (AFP) >50 ng/mL (>180.25 nmol/L). Subjects with an elevated indirect bilirubin and known Gilbert's disease can be included if direct bilirubin is within normal limits. Subjects with an AFP >50 ng/mL but <500 ng/mL can be included if CT scan or MRI performed within 3 months shows no evidence of HCC
  • Creatinine >1.2 mg/dL (>106.08 μmol/L) and creatinine clearance <50 mL/min (<0.83 L/s/m2)
  • Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
  • Evidence or history of HCC
  • Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects 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 (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
  • Subjects currently taking medication(s) that are transported through organic anion transporting polypeptide 1 (OATP1) including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
  • 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 subject will not be able to comply with the requirements of the protocol and complete the study
  • Any medical condition that, in the opinion of the Investigator, could interfere with evaluation of the study objectives or safety of the subjects

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong, Hong Kong Island

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

About this study

Official title: A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus

An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B treatment-naive subjects with chronic HBV infection.

Being tested
Inarigivir soproxil, Tenofovir alafenamide fumarate (TAF)
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

    Inarigivir soproxil 400 mg tablets

  • Tenofovir alafenamide fumarate (TAF)Drug

    Also called VEMLIDY

    Tenofovir alafenamide fumarate 25 mg tablet

Study groups in NCT04059198
Study groupRoleWhat they receive
Arm 1 - Inarigivir Soproxil DailyExperimentalInarigivir Soproxil Alone 400 mg Inarigivir daily for 12 weeks followed by 400 mg daily in combination with TAF 25 mg daily for 12 weeks
Receives: Drug: Inarigivir soproxil; Drug: Tenofovir alafenamide fumarate (TAF)
Arm 2 - Inarigivir Soproxil 3 Times WeeklyExperimental400 mg Inarigivir 3 times weekly for 12 weeks followed by 400 mg 3 times weekly in combination with TAF 25 mg daily for 12 weeks
Receives: Drug: Inarigivir soproxil; Drug: Tenofovir alafenamide fumarate (TAF)
Arm 3 - Inarigivir Soproxil and TAF DailyExperimental400 mg Inarigivir daily in combination with TAF 25 mg daily for 24 weeks
Receives: Drug: Inarigivir soproxil; Drug: Tenofovir alafenamide fumarate (TAF)

What is being measured

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

  1. Proportion of subjects reporting an adverse event, clinically significant adverse event, or laboratory abnormality

    Proportion of subjects reporting an adverse event or experiencing a clinically significant adverse event or laboratory abnormality from start of treatment to end of inarigivir treatment and 30 days after stopping inarigivir

    Measured: 24 to 52 weeks

  2. Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.3 log10 reduction in quantitative HBsAg

    Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.3 log10 reduction in quantitative hepatitis B surface antigen (HBsAg) from Baseline to Week 12.

    Measured: Baseline to Week 12

  3. Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.5 log10 reduction in quantitative HBsAg

    Percentage of subjects with a ≥1 log10 reduction in HBV DNA, a ≥1 log10 reduction in HBV RNA, and a ≥0.5 log10 reduction in quantitative hepatitis B surface antigen (HBsAg) from Baseline to Week 24.

    Measured: Baseline to Week 24

Secondary outcomes (23)

  1. Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10

    Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Week 4

    Measured: Week 4

  2. Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10

    Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Week 12

    Measured: Week 12

  3. Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10

    Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Weeks 24

    Measured: Week 24

  4. Change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10

    Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP-10 at Weeks 48

    Measured: Week 48

  5. Percentage of subjects who have a ≥0.5 log10 reduction in HBsAg

    Percentage of subjects who have a ≥0.5 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 12

    Measured: Week 12

  6. Percentage of subjects who have a ≥0.5 log10 reduction in HBsAg

    Percentage of subjects who have a ≥0.5 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 24

    Measured: Weeks 24

  7. Percentage of subjects with undetectable HBV DNA and HBV RNA

    Percentage of subjects with undetectable hepatitis B virus (HBV) DNA and HBV RNA at Week 24

    Measured: Week 24

  8. Percentage of subjects with ≥1 log10 reduction in HBsAg

    Percentage of subjects with ≥1 log10 reduction in hepatitis B surface antigen (HBsAg) at Week 24

    Measured: Week 24

  9. Percentage of subjects with undetectable HBV DNA and HBV RNA

    Percentage of subjects with undetectable hepatitis B virus (HBV) DNA and HBV RNA at Week 48

    Measured: Week 48

  10. Percentage of subjects with normal ALT

    Percentage of subjects with normal alanine aminotransferase (ALT) at Week 48

    Measured: Week 48

  11. Percentage of Subjects who were HBeAg-positive at Baseline with loss of HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 24

    Measured: Week 24

  12. Percentage of Subjects who were HBeAg-positive at Baseline with loss of HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 48

    Measured: Week 48

  13. Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 0.5 log10 reduction in HBeAg at Week 12

    Measured: Week 12

  14. Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 0.5 log10 reduction in HBeAg at Week 24

    Measured: Week 24

  15. Percentage of Subjects who were HBeAg-positive at Baseline with > 0.5 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 0.5 log10 reduction in HBeAg at Week 48

    Measured: Week 48

  16. Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 1 log10 reduction in HBeAg at Week 12

    Measured: Week 12

  17. Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 1 log10 reduction in HBeAg at Week 24

    Measured: Week 24

  18. Percentage of Subjects who were HBeAg-positive at Baseline with > 1 log10 reduction in HBeAg

    Percentage of Subjects who were hepatitis B e-antigen (HBeAg)-positive at Baseline with > 1 log10 reduction in HBeAg at Week 48

    Measured: Week 48

  19. Percentage of Subjects who enter the Long-term Follow-up Period with undetectable HBV DNA and HBV RNA

    Percentage of Subjects who enter the Long-term Follow-up Period with undetectable heaptitis B virus (HBV) DNA and HBV RNA at Week 72

    Measured: Week 72

  20. Percentage of Subjects who enter the Long-term Follow-up Period who remain HBV DNA <2000 IU

    Percentage of Subjects who enter the Long-term Follow-up Period who remain hepatitis B virus (HBV) DNA <2000 IU at Week 72

    Measured: Week 72

  21. Percentage of Subjects who enter the Long-term Follow-up Period with HBsAg loss

    Percentage of Subjects who enter the Long-term Follow-up Period with hepatitis B surface antigen (HBsAg) loss at Week 72

    Measured: Week 72

  22. Percentage of Subjects who enter the Long-term Follow-up Period with normal ALT

    Percentage of Subjects who enter the Long-term Follow-up Period with normal alanine aminotransferase (ALT) at Week 72

    Measured: Week 72

  23. Percentage of Subjects who enter the Long-term Follow-up Period who were HBeAg-positive at Baseline with loss of HBeAg

    Percentage of Subjects who enter the Long-term Follow-up Period who were hepatitis B e-antigen (HBeAg)-positive at Baseline with loss of HBeAg at Week 72

    Measured: Week 72

Timeline

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

  1. First posted16 Aug 2019
  2. Study start10 Oct 2019
  3. Primary completion2 Apr 2020
  4. Study completion2 Apr 2020

Why it stopped: Evidence of liver injury in a separate Inarigavir study

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059198
Sponsor's protocol ID
SBP-9200-HBV-207
Status last verified
Jul 2020
First submitted
14 Aug 2019
Last updated
21 Jul 2020
Results posted
No
Data monitoring committee
Yes
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 and Tenofovir alafenamide fumarate (TAF) in people with Hepatitis B and HBV, run by F-star Therapeutics, Inc. at 2 sites in Hong Kong.

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 12 inclusion and 23 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. 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: Evidence of liver injury in a separate Inarigavir study). 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?

Proportion of subjects reporting an adverse event, clinically significant adverse event, or laboratory abnormality (time frame: 24 to 52 weeks). The study lists 3 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 NCT04059198.

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 21 Jul 2020.

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