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临床试验/EUCTR2020-002118-42-DE
EUCTR2020-002118-42-DE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)

Altimmune, Inc.0 个研究点目标入组 80 人开始时间: 2020年8月21日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
80
研究概览入排标准研究者记录与标识符相似试验

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 (The history of HBsAg positivity may be reduced to 6 months provided HBV anti-core IgM antibodies are negative)
  • •5. qHBsAg = 10 IU/mL but = 200 IU/mL in the 12 months prior to screening or from informed consent to randomization
  • •If a patient has more than one qHBsAg value within 12 months and prior to randomization, the patient will be deemed eligible if any one measurement is within the eligible range.
  • •6. 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. Note: ALT and AST elevations up to 1.5 x ULN are allowed if evidence of hepatic steatosis, defined as one of the following criteria: 1) fatty liver on ultrasound, or other imaging modality or Fibroscan controlled attenuation parameter (CAP) = 260 dB/m. To qualify under these conditions, HBV DNA must be <2,000 IU/mL, and there must be no history or signs of liver disease other than fatty liver and HBV.
  • •7. Negative drug screen at screening unless prescribed by a medical practitioner for medical use (NB, recreational and prescription cannabis is allowed)
  • •8. 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.
  • •9.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 (Inclusion Criterion 8) apply to men with sexual partners of childbearing potential
  • •10. Willingness to comply with all aspects of the study through the entire study period
  • •Patients who fail to meet Inclus

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 6 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, as documented by imaging or Fibroscan CAP, is permitted if ALT and AST are <1.5 x ULN and HBV DNA <2,000 IU/mL and there is no history or signs of liver disease other than fatty liver and HBV)
  • •8. 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 before screening, or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified.)
  • •9. History of cirrhosis or signs of hepatic decompensation, including but not limited to variceal bleeding, ascites, or hepatic encephalopathy
  • •10. White blood cell count < 3,500/µL, neutrophils < 1,000/µL, hemoglobin < 11 g/dL, or platelets < 125,000/µL
  • •Note: Individuals of African descent with a white blood cell count <3,500/ µL will not be excluded for this reason if white blood cell count is = 2,500/µL, provided that the neutrophil count is = 1,000/µL and there is no other identified cause of leukopenia.
  • •11. Prior treatment with an approved or investigational agent for HBV
  • •12. History of conditions associated with immunocompromise
  • •13. History of conditions associated with altered immune response, such as anaphylaxis, angioedema, or autoimmune disease
  • •14. 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
  • •15. Uncontrolled diabetes mellitus, defined as Hemoglobin A1C (HbA1C) = 10% at screening
  • •16. 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
  • •17. 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 chronically using aspirin, non-steroidal anti-inflammatory agents, antacids, vitamins, probiotics, and over-the-counter medications will maintain their level of intake throughout the study)
  • •18. 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)
  • •19. Untreated alcohol or drug abuse
  • •20. Planned elective surgery or hospitalization during the study period
  • •21. Participation in a prior trial involving HepTcell or FP-02.2
  • •22. Known allergy to any of the ingredients in HepTcell
  • •23. Receipt of any investigational drug or treatment within 30 days before Day 1 or planned use during the study period
  • •24. Any medical, psychiatric, or social c

研究者

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