A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis. - NASH-RX

Galectin Therapeutics Inc.0 个研究点目标入组 395 人开始时间: 2020年12月29日最近更新: 2023年9月11日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Galectin Therapeutics Inc.
入组人数: 395

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

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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. Is male or female, = 18 and = 75 years of age at the time of Screening.
•2. Is willing and able to provide written informed consent prior to the
•initiation of any study-specific procedures.
•Has evidence of portal hypertension, with
•3. either one of the following:
•a. platelet count <150,000/mm3
•b. documented HVPG measurement >6 mmHg
•c. at least two of the following:
•- spleen size = 14 cm (documented by ultrasound, MRI, or CT scan)
•- abdominal collateral circulation (documented by ultrasound, MRI, or CT
•scan, or physical examination, ie, caput medusae)
•- documented liver transient elastography (eg, FibroScan) =20 kPa
•- AST/ALT >1.
•4. Has a history confirming NASH cirrhosis, with at least one of the following:
•There is a historical liver biopsy showing cirrhosis with steatohepatitis. There is no evidence for a competing etiology for the cirrhosis.
•There is a historical liver biopsy showing steatohepatitis, and there is evidence of cirrhosis from clinical or imaging data or a second liver biopsy showing cirrhosis without all features of NASH (as the histological NASH lesions may have burnt out). There is no evidence for a competing etiology. There is at least 1 co-existing or history of metabolic comorbidity at Screening: obesity (with either body mass index [BMI] =30 kg/m2 or waist circumference =102 cm [40 in, men] or =88 cm [35 in, women], or by ethnically appropriate cutpoints); hypertension (either on anti hypertensive drug therapy for at least 1 year or systolic/diastolic BP >140/80 mm Hg); Type 2 diabetes (glycated hemoglobin [HbA1c] =6.5%, or on anti-diabetic medication for at least 1 year); or dyslipidemia (triglycerides =150 mg/dL or on drug therapy for hypertriglyceridemia for at least 6 months; high-density lipoprotein cholesterol =40 mg/dL [men] or =50 mg/dL [women]) to corroborate a diagnosis of NAFLD.
•There is a historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis. There is no evidence for a competing etiology. There are at least 2 co-existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
•There is a historical liver biopsy showing steatosis but now with cirrhosis either by physical examination, imaging, or biopsy. If there is a current biopsy, it does not show evidence of steatosis or steatohepatitis as histological lesions may have burned out. There is no evidence for a competing etiology. There are at least 2 co existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
•Patient with cirrhosis with current or previous imaging showing
•steatosis. There is no liver histology available. There is no evidence for a
•competing etiology. There are at least two co-existing or history of
•metabolic comorbidities with obesity or diabetes being one of them to
•corroborate a diagnosis of NAFLD.
•For patients not meeting the above mentioned criteria, a screening liver biopsy is necessary.
•5. Absence of HCC by valid imaging (e.g. ultrasound, CT scan or MRI)
•within 6 months prior to randomization. If no such imaging result is
•available, then it should be performed as part of standard of care.
•6. Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is =9.5%.
•7. Patients on vitamin E or pioglitazone can

排除标准

•1. Presence of esophageal, gastroesophageal, or isolated gastric varices,
•based on an upper GI EGD exam conducted during Screening. Patients
•with portal hypertensive gastropathy could be enrolled.
•2. History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous
•bacterial peritonitis or overt hepatic encephalopathy (West Haven grade =2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening.
•3. Known or suspected abuse of alcohol, as per medical history. 4.
•4. Alcohol dependence.
•5. Narcotics or any other drug abuse or dependence in the last 5 years
•6. Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt
•7. Documented causes of liver disease other than NASH, including but
•not restricted to:
•Viral hepatitis, unless eradicated at least 3 years prior to Screening
•acute hepatitis A infection (presence of hepatitis A immunoglobulin M
•[IgM] at Screening)
•positive hepatitis B surface antigen
•positive hepatitis C virus (HCV) ribonucleic acid (to be performed prior
•to randomization in case of positive HCV antibody)
•Documented drug-induced liver disease
•Alcoholic liver disease
•Autoimmune hepatitis
•Wilson's disease
•Hemochromatosis
•Primary biliary cholangitis
•Primary sclerosing cholangitis
•Genetic hemochromatosis
•History or planned liver transplantation
•Alpha-1 antitrypsin deficiency
•8. History of human immunodeficiency virus (HIV), or positive HIV test
•at Screening
•9. Any of the following test or score
•serum ALT > 5 × upper limit of normal (ULN)
•serum AST > 5 × ULN
•serum ALP > 2 × ULN
•mean platelet count < 150,000/mm3
•albumin = 3.5 g/dL
•INR =1.5 (without anticoagulant therapy)
•total bilirubin = 2.0 mg/dL (subjects with a documented history of
•Gilbert's syndrome can be enrolled if the direct bilirubin is within normal
•reference range)
•MELD score >12
•CTP Score =7
•estimated creatinine clearance < 45 mL/min
•10. Taking an angiotensin converting enzyme inhibitor, angiotensin II
•receptor blocker, or ß-1 selective adrenergic receptor inhibitor, unless
•on a stable regimen for at least 3 months prior to Screening, and no
•changes in the regimen are anticipated during the study. Subjects taking a non-selective beta blocker are not eligible to be enrolled (Investigators are encouraged to substitute another medication, if clinically warranted).
•11. History of major surgery during the Screening.
•12. History of a solid organ transplant requiring immunosuppressive
•13. History of bariatric surgery within 1 year of randomization, or plan to undergo bariatric surgery during the study.
•14. Has positive screening test for illicit drugs of abuse at Screening.
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研究者

发起方

Galectin Therapeutics Inc.

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