EUCTR2019-001629-28-PL进行中（未招募）1 期
A Phase 2a, randomized, double-blind, placebo-controlled study of oral FXR modulator EYP001a combined with nucleos(t)ide analogues (NA) in virologically suppressed chronic hepatitis B patients to improve functional cure rates
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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
入选标准
- •1. Has given voluntary written informed consent before performance of any study related procedure.
- •2. Must be 18 to 65 years of age, inclusive
- •3. Are on stable NA therapy for at least 12 months from the screening date (ETV or TDF)
- •4. Has virally suppressed CHB:
- •a. HBV DNA < LLOQ and serum HBsAg >100 IU/mL
- •5. Has liver imaging to screen for hepatocellular carcinoma or concomitant pancreaticobiliary disease either in the prior 6 months or at screening.
- •6. Has liver tests during the Screening Period defined as follows:
- •a. The baseline values (i.e. two measurements at least 3 days apart: one can be from medical history if not older than 12 months and one during screening period) with both measurements of ALT or AST are = 2 × ULN
- •b. Normal or clinically not relevant levels of ALP (= 1.5 ULN)
- •c. Has total bilirubin (TBL) = 22.2 µmol/L, which corresponds to = 1.3 mg/dL.
- •d. Has conjugated (direct) bilirubin of = 0.3 mg/dL (i.e. 5.1 µmol/L)
- •e. Has normal or clinically not relevant levels of GGT (= 2.0 ULN)
- •f. International normalized ratio = 1.2 x ULN, unless on anticoagulant therapy
- •g. Platelet count = 100 G/L
- •h. Has albumin =3.5 g/dL.
- •7. Is not of childbearing potential or, if of childbearing potential, is not pregnant as confirmed by a negative serum human chorionic gonadotropin test at screening and is not planning a pregnancy during the course of the study.
- •8. Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use a dual method of contraception as defined in the study protocol or practice complete abstinence from sexual intercourse if this is the patient’s usual and preferred lifestyle throughout the duration of the study and for 90 days after stopping study drug. Patients who are using hormonal contraceptives should be instructed to use an additional contraceptive measure during the study. Note: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for >12 consecutive months without an alternative medical cause.
- •A follicle stimulating hormone level in the postmenopausal range will be used to confirm a postmenopausal state in women <55 years of age. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- •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 49
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Is an employee of a CRO, vendor, or Sponsor involved with this study
- •2. Has known hepatocellular carcinoma or pancreaticobiliary disease
- •3. Neutropenia (defined by two confirmed values within screening period of <1500/µL)
- •4. Has Gilbert syndrome
- •5. Shows evidence of worsening liver function, defined as either a confirmed (two assessments at least 3 days apart) increase >2 ULN ALT or AST or an increase of >1.5 × first assessed value of TBL or associated with clinical signs or symptoms of liver impairment.
- •6. Has known or suspected non CHB liver disease, including, but not limited to, Hepatitis D virus co-infection, alcoholic liver disease, non alcoholic steatohepatitis diagnosed with liver biopsy, autoimmune disease, HIV, active hepatitis C virus (HCV ), Wilson disease, hemochromatosis, hepatocellular carcinoma (normal AFP at screening required) or suspected or known other liver cancer, primary biliary cholangitis, primary sclerosing cholangitis, drug induced liver injury (DILI), bile duct obstruction.
- •7. History of cirrhosis or liver decompensation, including ascites, hepatic encephalopathy, or presence of oesophageal varices
- •8. Probable or possible F3 stage with a vibration controlled transient elastography (VCTE). Patients with normal baseline ALT and VCTE >8.8 kPa are excluded. Patients with baseline ALT >ULN (but <2ULN per EC5) and who have VCTE >10.5 kPa at baseline are excluded
- •9. Has known history of alcohol abuse or daily heavy alcohol consumption (females: >14 units of alcohol per week; males: >21 units of alcohol per week [1 unit of alcohol is equivalent to a half pint of beer {285 mL}, 1 measure of spirits {25 mL}, or 1 glass of wine {125 mL}]). Has an AUDIT C score of >3 points for men and women AND a full AUDIT score of >8 points at screening.
- •10. Is pregnant or breastfeeding
- •11. Has clinically relevant immunosuppression, including, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- •12. Has a known pre existing medical or psychiatric condition that could interfere with the patient’s ability to provide informed consent or participate in study conduct, or that may confound study findings.
- •13. Has known dyslipidaemia with higher cardio-vascular risk from worsening lipid parameters (history of clinically significant cardiovascular or cerebrovascular disease during 12 months prior to study entry).
- •14. Has, in the opinion of the Investigator, clinically significant cardiovascular or cerebrovascular disease within 12 months prior to the first study drug administration, including, but not limited to, myocardial infarction, acute coronary syndrome, revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or ischemic stroke, or implanted defibrillator or pacemaker
- •15. Has participated in any study with administration of an investigational drug in the past 30 days, or 5 half lives, whichever is longer, prior to the first study drug administration in the current study
- •16. Has had major visceral or orthopaedic surgery within 30 days prior to the first study drug administration in the current study
- •17. Has a hypersensitivity to the study drug or to any of the excipients or placebo
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