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临床试验/ACTRN12618001843246
ACTRN12618001843246尚未招募1 期

A Phase 1b Open-Label, Proof of Concept Study to Evaluate the Safety and Efficacy of Novel Hepatitis B Virus (HBV) Combination Therapies in Chronic Hepatitis B (CHB) Subjects

Gilead Sciences, Inc0 个研究点目标入组 36 人开始时间: 2018年11月13日最近更新:
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适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
36
研究概览研究设计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
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years（—）
性别
All

入选标准

  • •1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • •2) Adult male and non-pregnant, non-lactating female subjects, 18-65 years of age inclusive based on the date of the Screening visit
  • •3) Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) with detectable HBsAg levels at Screening
  • •4) Have been on a commercially available HBV nucleos(t)ide treatment(s) (tenofovir
  • •alafenamide, tenofovir disoproxil fumurate, entecavir, adefovir, lamivudine, telbivudine,
  • •either as single agents or in combination) with no change in regimen for 3 months prior to
  • •5) Have a historic HBV DNA <69 IU/mL, measured at least once at local laboratory, 3 or more months prior to screening
  • •6) HBV DNA < 20 IU/mL by central laboratory at Screening
  • •7) Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia’s formula) =< 450 msec for males and =< 470 msec for females.
  • •8) Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline prior to enrollment
  • •9) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • •10) Must be willing and able to comply with all study requirements

排除标准

  • •1) Extensive bridging fibrosis or cirrhosis as defined clinically by any one of the following:
  • •a) Metavir >= 3 or Ishak fibrosis score >= 4 by a liver biopsy within 3 years of screening, or,
  • •in the absence of an appropriate liver biopsy, either:
  • •b) Screening FibroTest score of > 0.48 and APRI > 1 by central laboratory, or
  • •c) Historic FibroScan with a result > 9 kPa within =< 1 year of screening
  • •If liver biopsy is available, the liver biopsy result supersedes (b) and/or (c, if available)
  • •If an appropriate liver biopsy is not available, fibrosis will be evaluated by (b) and/or
  • •(c, if available). In the event of discordance between (b) and (c), the FibroScan results will
  • •take precedence.
  • •2) Subjects meeting any of the following laboratory parameters at screening:
  • •a) Hemoglobin < 12 g/dL (for males) or <11 g/dL (for females)
  • •b) White Blood cell count < 2500 cells/mm3
  • •c) Neutrophil count < 1500 cell/mm3 (or < 1000 cell/mm3 if considered a physiological
  • •variant in a subject of African descent)
  • •d) ALT > 3x ULN
  • •e) INR > ULN unless the subject is stable on an anticoagulant regimen affecting INR
  • •f) Albumin < 3.5 g/dL
  • •g) Direct bilirubin >1.5x ULN
  • •h) Platelet Count < 100,000/uL
  • •i) Positive autoantibodies, defined as any one or more of the following:
  • •i) Antinuclear antibodies (ANA) >1:80
  • •ii) Smooth muscle antibodies (anti-SMA) >1:80
  • •iii) Antimitochondrial antibodies (AMA) >1:40
  • •iv) Anti-thyroid peroxidase (anti-TPO) >1:40
  • •j) Estimated creatinine clearance (CrCl) < 60 mL/min (using the Cockcroft-Gault method)
  • •based on serum creatinine and actual body weight as measured at the screening
  • •3) Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
  • •hepatitis D virus (HDV). Subjects who are HCV Ab or HDV Ab positive, but have a
  • •documented negative HCV RNA or HDV RNA, respectively, are eligible.
  • •4) Current or prior history of hepatocellular carcinoma (HCC) (e.g. as evidenced by prior
  • •imaging) or screening alpha-fetoprotein (AFP) >= 50 ng/mL without imaging to rule out HCC
  • •5) Current or prior history of clinical hepatic decompensation (e.g. ascites, encephalopathy, or variceal hemorrhage).
  • •6) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g. basal cell skin cancer). Subjects under evaluation for
  • •possible malignancy are not eligible
  • •7) Significant cardiovascular, ophthalmological, pulmonary, or neurological disease in the
  • •opinion of the investigator
  • •8) Diagnosis of any autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid
  • •arthritis, inflammatory bowel disease, ulcerative colitis, pneumonitis, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis, autoimmune nephritis, thyroiditis), poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), hemoglobinopathy, retinal disease, or are immunosuppressed
  • •9) Chronic liver disease of a non-HBV etiology (e.g. Wilson’s disease, hemochromatosis,
  • •alpha-1-antitrypsin deficiency, cholangitis), except for non-alcoholic fatty liver disease
  • •10) Received solid organ or bone marrow transplant
  • •11) Received prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics
  • •(e.g. monoclonal antibody, interferon, nivolumab) within 3 months of screening
  • •12) Have received inactivated vaccinations (e.g. injectable influenza or pneumococcal) within 4 weeks

研究者

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