Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices iā¦ (NCT04365868) | Clinical Trial Compass
TerminatedPhase 2/3
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Stopped: Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.
United States357 participantsStarted 2020-06-25
Plain-language summary
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Is male or female, ā„ 18 and ā¤ 75 years of age at the time of Screening.
ā. Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
ā. Has evidence of portal hypertension, with either one of the following:
ā. Has a history confirming nonalcoholic steatohepatitis (NASH) cirrhosis, with at least one of the following:
ā. Absence of hepatocellular carcinoma (HCC) by valid imaging (eg, ultrasound, CT scan, or MRI) within 6 months prior to randomization. If no such imaging result is available, then ultrasound imaging should be performed as part of standard of care.
Exclusion criteria
ā. Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening. Patients with portal hypertensive gastropathy could be enrolled.
What they're measuring
1
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo
ā. 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 ā„2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening.
ā. Known or suspected abuse of alcohol (\>20 g/day for women or \>30 g/day for men \[on average per day\]), as per medical history. Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males. On average, a standard drink in the United States is considered to be 14 grams of alcohol, equivalent to 12 fluid ounces of regular beer (5% alcohol), 5 fluid ounces of table wine (12% alcohol), or 1.5 fluid ounces of 80 proof spirits (40% alcohol).
ā. Alcohol dependence (ie, a score \>8 on the Alcohol Use Disorders Identification Test)
ā. Narcotics or any other drug abuse or dependence in the last 5 years