EUCTR2020-002118-42-IT进行中（未招募）1 期
Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment naïve Patients with Inactive Chronic Hepatitis B (CHB) - n.a.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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, treatment-naïve 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, 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •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 < 150,000/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-attenuated replicating vaccines within 30 days or receipt of any other licensed or authorized vaccines (including vaccines intended to prevent COVID-19) within 14 days prior to Day 1
- •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
研究者
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