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临床试验/EUCTR2021-001445-12-ES
EUCTR2021-001445-12-ES进行中（未招募）1 期

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)

Gilead Sciences, Inc.0 个研究点目标入组 440 人开始时间: 2021年10月8日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
440
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)Men and women between 18 and 80 years of age, inclusive, based on the date of the screening visit
  • •2)Willing and able to give informed consent prior to any study-specific procedures being performed
  • •3)Cirrhosis (F4) due to NASH as defined in the protocol
  • •4)The following laboratory parameters at screening, as determined by the central laboratory:
  • •a)Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73m2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation to estimate creatinine clearance (CLcr)
  • •b)HbA1c = 10% (or serum fructosamine = 400 umol/L if HbA1c is not quantifiable)
  • •c)Hemoglobin > 10.6 g/dL
  • •d)INR = 1.4, unless due to therapeutic anticoagulation
  • •e)Total bilirubin = 1.3 x ULN (unless due to an alternative etiology such as Gilbert’s syndrome or hemolytic anemia)
  • •f)Serum albumin = 3.5 g/dL
  • •g)Serum ALP = 2 x ULN
  • •h)Platelet count = 125,000/uL
  • •i)Serum triglyceride level = 250mg/dL. If initial screening value is >250 mg/dL, triglycerides may be retested during the screening period. Fasting serum triglycerides must be confirmed to be = 250 mg/dL prior to Day 1. Management of hypertriglyceridemia may be initiated or modified at investigator discretion during the screening period (Section 7.7.4.1).
  • •j)ALT < 5 x ULN
  • •5)BMI = 23 kg/m2 at screening
  • •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 330
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 110

排除标准

  • •1)Any history of decompensated liver disease in the opinion of the investigator, including clinically relevant ascites, hepatic encephalopathy (HE), or variceal bleeding
  • •2)Child-Pugh (CP) score > 6 at screening, unless due to an alternative etiology such as Gilbert’s syndrome or therapeutic anticoagulation
  • •3)Model for End-stage Liver Disease (MELD) score >12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation
  • •4)Chronic HBV infection (HBsAg positive)
  • •5)Chronic HCV infection (HCV antibody and HCV RNA positive). Subjects cured of HCV infection less than 2 years prior to the screening visit are not eligible.
  • •6)Other causes of liver disease based on medical history and/or central pathologist review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, PBC, PSC, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
  • •7)History of liver transplantation
  • •8)Current or prior history of HCC
  • •9)HIV infection
  • •10)Weight loss >10% within 180 days of screening, or >5% between the date of the biopsy used for eligibility and the date of screening
  • •11)Any weight reduction surgery or procedure in the 2 years prior to screening or malabsorptive weight loss surgery (eg, Roux-en-Y or distal gastric bypass) at any time prior to screening
  • •12)History of intestinal resection that could result in malabsorption of study drug
  • •13)Planned coronary, carotid, or peripheral artery intervention or unstable cardiovascular disease in the opinion of the investigator
  • •14)History of uncontrolled chronic pulmonary disease in the opinion of the investigator within 180 days prior to screening
  • •15)Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol
  • •16)Positive urine drug screen for amphetamines, cocaine, or opiates at screening, unless due to a prescription medication
  • •17)Use of any prohibited concomitant medication prior to enrollment
  • •18)Participation in another investigational study of a drug or device within 30 days or within 5 half-lives of the prior investigational agent (whichever is longer) prior to the date of screening and through the end of the study. Participation in a study of an investigational device may be approved by the medical monitor or designee.
  • •19)History of malignancy within 5 years of screening with the following exceptions:
  • •a)Adequately treated carcinoma in situ of the cervix
  • •b)Adequately treated basal or squamous cell cancer or other localized nonmelanoma skin cancer
  • •20)For subjects with type 2 diabetes diagnosed prior to the date of the screening visit OR based on screening visit results (HbA1c = 6.5% or fasting plasma glucose = 126 mg/dL, confirmed on repeat testing), subjects must have no evidence of uncontrolled and potentially unstable retinopathy or maculopathy as determined by a fundoscopic examination performed starting 90 days prior to screening visit date through Day 1. If there has been worsening of the subject’s visual function since a historical fundoscopic examination in the opinion of the investigator, then the fundoscopic examination must be repeated prior to Day 1 for eligibility. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.
  • •21)Acute pancreatitis within 180 days prior to screening
  • •22)History or presence of chroni

研究者

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