EUCTR2019-001983-31-DE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. - NAVIGATE
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
入排标准
- 性别
- All
入选标准
- •1.Male or female, = 18 and = 75 years old.
- •2.Willing and able to provide written informed consent.
- •3.Has evidence of portal hypertension, with either one:
- •a.platelet count <150K/mm3 (from central laboratory or historical record, e.g. detailed chart notes providing platelet numbers or copies of laboratory reports showing platelet count[s] below 150K/mm3)
- •b. documented HVPG measurement >6 mmHg
- •c. at least two of the following:
- •-spleen size = 14 cm
- •-abdominal collateral circulation
- •-documented liver transient elastography =20 kPa
- •-AST / ALT >1
- •4.History confirming NASH cirrhosis, with at least one:
- •Historical liver biopsy showing cirrhosis with steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate cirrhosis with steatohepatitis).
- •Historical liver biopsy showing steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate 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.
- •Historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate cirrhosis with steatosis).
- •Historical liver biopsy showing steatosis (if slides or blocks are not available, the biopsy report must clearly indicate 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 within 6 months prior to randomization.
- •6.Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is =9.5%.
- •7.Patients on therapeutic doses of vitamin E or pioglitazone can be enrolled if they are on a stable regimen for at least 3 months before screening, and the regimen is expected to be held constant during the trial.
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. 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 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 (patients on warfarin will be exempt from this criterion)
- •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 therapy.
- •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. Positive marijuana/cannabinoids (THC) usage is not an automatic exclusion but rather should be based upon local requirements where applicable.
- •15.Has participated in an investigational new drug study within 30 days or 5 half-lives whichever is longer, prior to randomization.
- •16.Has a history of malignancy within 5 years of randomization, except for basal cell carcinoma, squamous cell carcinoma and adequately treated in situ uterine cervical cancer.
- •17.Has clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring interven
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