EUCTR2019-000896-17-GB进行中（未招募）1 期
A PHASE 2, EXPLORATORY STUDY EVALUATING THE SAFETY AND ANTIVIRAL EFFICACY OF INARIGIVIR SOPROXIL IN NON-CIRRHOTIC, HEPATITIS B e ANTIGEN NEGATIVE SUBJECTS INFECTED WITH CHRONIC HEPATITIS B VIRUS AND RECEIVING OR STOPPING TREATMENT WITH A NUCLEOSIDE/NUCLEOTIDE INHIBITOR - Phase 2 safety and antiviral efficacy study of inarigivir
Spring Bank Pharmaceuticals, Inc.0 个研究点目标入组 60 人开始时间: 2020年9月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Participants in all cohorts must meet all the following inclusion criteria to be enrolled into the study:
- •1. HBV-infected male and female participants aged 18 to 70 years, inclusive
- •2. Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 6 months of enrollment (Cohort 1) or randomisation (Cohort 2) date with no evidence of cirrhosis or hepatocellular carcinoma (HCC)
- •3. Must be willing and able to comply with all study requirements
- •4. Have HBV DNA 5. ALT normal or, if elevated, <2× ULN with a documented etiology for elevation such as non-alcoholic fatty liver disease (NAFLD) confirmed by either ultrasound or controlled attenuation parameter (CAP) score >280 on elastography
- •6. 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
- •7. Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.
- •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 sterilisation, or total abstinence from heterosexual intercourse, when this is the preferred and usual
- •lifestyle of the participant.
- •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.
- •8. Must have the ability to understand and sign a written informed consent form (ICF); consent must be obtained prior to initiation of study procedures
- •In addition, participants must meet the cohort-specific criteria listed below:
- •a. HBeAg-negative participants on documented NUCs for =3 years with undetectable HBV DNA by polymerase chain reaction (PCR) documented at least annually over the last 2 years. NUCs can include tenofovir, entecavir, telbivudine, lamivudine, adefovir, and tenofovir-5TC.
- •b. HBsAg <1000 IU at Screening
- •c. Planning to discontinue NUC therapy
- •a. HBeAg-negative participants on documented NUCs for =1 year with undetectable HBV DNA by PCR documented on at least 1 occasion in the last 6 months. NUCs can include tenofovir, entecavir, telbivudine, lamivudine, adefovir, and tenofovir-5TC.
- •b. Planning to continue NUC therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Participants in all cohorts who meet any of the following exclusion criteria are not eligible to be enrolled into the study:
- •1. Any prior liver biopsy evidence of metavir F3 or F4 disease
- •2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
- •3. Evidence of advanced fibrosis as defined by Fibroscan at the Screening Visit of =8 kPa. If Fibroscan is not available, participants with both a Fibrotest =0.65 and aspartate transaminase (AST):platelet ratio index (APRI) =1.0 are excluded (participants will not be excluded if only 1 of the Fibrotest or APRI results is higher than allowed)
- •4. Laboratory parameters not within defined thresholds:
- •4.1 White blood cells <4000 cells/µL (<4.0×109/L)
- •4.2 Haemoglobin <11 g/dL (<110 g/L) for females, <13 g/dL (<130 g/L) for males
- •4.3 Platelets <130,000 per µL (<130×109/L)
- •4.4 Albumin <3.5 g/dL (<35 g/L)
- •4.5 International normalised ratio (INR) >1.5
- •4.6 Total bilirubin >1.2 mg/dL (>20.52 µmol/L) or alpha-fetoprotein (AFP) >50 ng/mL (>180.25 nmol/L). Participants with an elevated indirect bilirubin and limits. Participants 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
- •4.7 Creatinine >1.2 mg/dL (>106.08 µmol/L) and creatinine clearance <50 mL/min (<0.83 L/s/m2)
- •5. Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
- •6. Evidence or history of HCC
- •7. Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible
- •8. Significant cardiovascular, pulmonary, or neurological disease
- •9. Received solid organ or bone marrow transplant
- •10. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
- •11. Participants 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
- •12. Use of another investigational agent within 3 months of Screening
- •13. Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
- •14. Females who are pregnant or may wish to become pregnant during the study
- •15. If the Investigator believes the prospective participant will not be able to comply with the requirements of the protocol and complete the study
- •16. Any medical condition that, in the opinion of the Investigator, could interfere with evaluation of the study objectives or safety of the participants
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