| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Inactive Chronic Hepatitis B (CHB) |
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| E.1.1.1 | Medical condition in easily understood language |
| Inactive Chronic Hepatitis B (CHB) |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10008910 |
| E.1.2 | Term | Chronic hepatitis B |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To assess virologic response to HepTcell in treatment-naïve patients with inactive CHB
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| E.2.2 | Secondary objectives of the trial |
•To assess cellular immune response of HepTcell in treatment-naïve patients with inactive CHB
•To assess the safety of HepTcell in treatment-naïve patients with inactive CHB
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Able and willing to provide informed consent
2. Men and women 18 to 65 years of age, inclusive
3. Body Mass Index (BMI) 18.0 to 34.9 kg/m2, inclusive
4. Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1 (NB, if the duration of infection cannot be established, the patient may participate if HBV anti-IgM antibodies are negative)
5. qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
6. HBV DNA ≥ 10 IU/mL at screening
7. AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome, who will only be eligible for study participation if total bilirubin is ≤ 3.0 mg/dL) and direct bilirubin within normal limits at screening
8. Negative drug screen at screening (NB, recreational and prescription cannabis is allowed)
9. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]):
a. Negative pregnancy test on Day 1
b. Willingness to practice a highly effective method of birth control with low user dependency from screening through one menstrual cycle after the last dose of study medication, which include:
i. Abstinence
ii. Sex only with persons of the same sex
iii. Monogamous relationship with vasectomized partner
iv. Intrauterine device
v. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
vi. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
vii. Intrauterine hormone-releasing system
Patients who practice true abstinence or who exclusively have same sex partners need not use contraception, provided it is in line with their preferred and usual lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Should any such patient stop practicing abstinence, they must use contraception as described above.
10.For men with sexual partners of childbearing potential, as defined above:
a. Abstinence
b. History of vasectomy or surgical sterilization
c. Monogamous relationship with a postmenopausal or surgically sterilized partner
d. Willingness to practice a highly effective method of contraception, as defined above, and supplemented by the use of a condom for 90 days after the last dose of study medication and to refrain from sperm donation for this time
The same criteria pertaining to abstinence and withdrawal methods in women of childbearing potential (Exclusion Criterion 9) apply to men with sexual partners of childbearing potential.
11. Willingness to comply with all aspects of the study through the entire study period
Patients who fail to meet Inclusion Criteria 5 or 6 and otherwise meet the requirements for study participation will be permitted one additional blood draw to requalify.
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| E.4 | Principal exclusion criteria |
1. Pregnant or lactating women
2. Positive hepatitis B e antigen (HBeAg) at screening
3. History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
4. Prior or current history of active or untreated human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus (HDV)
5. Acute COVID-19, a positive test result for SARS-CoV2 infection, or exposure within 14 days to an individual with acute COVID-19
6. Febrile illness (temperature ≥ 38.0 °C) within the past 14 days
7. Prior or current history of any underlying liver disease not related to HBV (NB, steatosis is permitted if ALT and AST are normal)
8. Undetectable HBV DNA at screening
9. Fibroscan > 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified.)
10. History of cirrhosis or signs of hepatic decompensation, including but not limited to variceal bleeding, ascites, or hepatic encephalopathy
11. White blood cell count < 3,500/µL, neutrophils < 1,000/µL, hemoglobin < 11 g/dL, or platelets < 100,000/µL
12. Prior treatment with an approved or investigational agent for HBV
13. History of conditions associated with immunocompromise
14. History of conditions associated with altered immune response, such as anaphylaxis, angioedema, or autoimmune disease
15. Treatments known to affect the immune system, such as corticosteroids (other than topical or inhaled preparations), alkylating drugs, antimetabolites, cytotoxic drugs, radiation, immune-modulating biologics, allergy injections, immunoglobulins, interferons or other immunomodulating therapies, within 30 days of screening
16. Uncontrolled diabetes mellitus, defined as Hemoglobin A1C (HbA1C) ≥ 10% at screening
17. Receipt of live vaccines (such as live influenza vaccinations or live travel vaccinations) in the 30 days prior to the screening
18. Change in any chronically administered medication or treatment within 14 days of screening or inability to maintain these medications at the same dose through Day 169 (NB, patients using aspirin, non-steroidal anti-inflammatory agents, antacids, vitamins, probiotics, and over-the-counter medications will maintain their level intake throughout the study)
19. Malignancy within 3 years of screening, excluding non-melanoma skin cancers and carcinoma in situ cervical cancer (NB, patients who have undergone prior screening for HCC by imaging or alpha-fetoprotein levels will have negative test results)
20. Untreated alcohol or drug abuse
21. Planned elective surgery or hospitalization during the study period
22. Participation in a prior trial involving HepTcell or FP-02.2
23. Known allergy to any of the ingredients in HepTcell
24. Receipt of any investigational drug or treatment within 30 days before Day 1 or planned use during the study period
25. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a patient’s ability to give informed consent
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The proportion of patients achieving virologic response, defined as a 1.0-log reduction in qHBsAg, Baseline to Day 169 |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
•Proportion of patients achieving serologic clearance of HBsAg on Day 169
•Proportion of patients achieving serologic clearance of HBV DNA on Day 169
•Changes in qHBsAg, HBV DNA, HBcrAg, and pg-RNA levels, Baseline to Days 85 and 169
•Change in IFN-γ frequency by ELISpot in PBMCs, Baseline to Days 85 and 169
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 18 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Canada |
| Germany |
| Spain |
| United Kingdom |
| United States |
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| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 27 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 27 |
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