EUCTR2019-001983-31-ES进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 395
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. 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.
- •3. Has evidence of portal hypertension, with at least 2 of the following:
- •a. platelet count <150,000/mm3
- •b. spleen size = 15 cm (by documented MRI, CT scan, or ultrasound imaging)
- •c. collateral vessels (by documented MRI or ultrasound imaging or physical examination, ie, caput medusae)
- •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.
- •For patients without a historical liver biopsy with slides available for review by the central study pathologist, a screening liver biopsy is required.
- •5. Absence of HCC by valid imaging (liver ultrasound, triple phase CT or MRI of liver) 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 type 2 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 study enrollment, and their screening HbA1c is =9.5%.
- •7. Patients on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial.
- •8. Patients on a statin can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial.
- •9. Is not pregnant and must have a negative serum p
排除标准
- •1. Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper GI EGD exam conducted within 2 months of randomization. Patients with clearly defined gastric fundal varices should be excluded, but patients with gastropathy could be considered for enrollment after approval/discussion with the Medical Monitor.
- •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 after Screening but before randomization.
- •3. Known or suspected abuse of alcohol, as per medical history. 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 procedure
- •7. Documented causes of chronic liver disease other than NASH, including but not restricted to:
- •Viral hepatitis, unless eradicated at least 3 years prior to Screening
- •positive for hepatitis A
- •positive hepatitis B surface antigen
- •positive hepatitis C virus (HCV) ribonucleic acid (tested for in case of positive HCV antibody, at the latest 2 weeks prior to randomization)
- •Suspicion of drug-induced liver disease
- •Alcoholic liver disease
- •Autoimmune hepatitis
- •Wilson’s disease
- •Hemochromatosis
- •Primary biliary cholangitis (also termed primary biliary cirrhosis)
- •Primary sclerosing cholangitis
- •Genetic hemochromatosis
- •Known or suspected HCC
- •History or planned liver transplantation, or current MELD score =12
- •Alpha-1 antitrypsin deficiency
- •8. Type 1 diabetes or poorly controlled Type 2 diabetes mellitus (HbA1c >9.5%)
- •9. History of human immunodeficiency virus (HIV), or positive HIV test at Screening
- •10. Any of the following test or score values during Screening Visit (SV) 1, SV2, and SV3 (if required/available):
- •serum ALT > 5 × upper limit of normal (ULN)
- •serum AST > 5 × ULN
- •serum ALP > 1.5 × ULN
- •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
- •11. Taking a statin, angiotensin converting enzyme inhibitor, angiotensin II receptor blocker, or ß-1 selective adrenergic receptor inhibitor, unless on a stable dose and dosing regimen for at least 3 months prior to screening, and no changes in the dose or dosing regimen are anticipated during the entire study. Subjects taking a non-selective beta blocker are not eligible to be enrolled.
- •12. History of major surgery within 8 weeks of randomization, significant traumatic injury within 6 months, or anticipation of need for major surgical procedure during the course of the study.
- •13. History of a solid organ transplant requiring continuing immunosuppressive therapy.
- •14. History of bariatric surgery within 3 years of randomization, or plan to undergo weight reduction surgery or participate in weight reduction programs during the study.
- •15. Has positive screening test for illicit drugs of abuse, including, but not limited to, amphetamines, cocaine, or non-prescription opiates (eg, heroin, morphine) at Screening.
- •16. Has participated in an investigational new drug study within 30 days or 5 ha
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