Esophageal Varices in NASH Cirrhosis
Conditions
Brief summary
Proportion of patients in the belapectin treatment groups who develop esophageal varices at 78 weeks (18 months) of treatment compared to placebo.
Detailed description
Incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop any of:1)varices (esophageal or gastric) requiring treatment,2)variceal bleed requiring hospitalization,3)clinically significant ascites requiring hospitalization,4)spontaneous bacterial peritonitis,5)overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization),6)mortality(all-cause),7)liver transplant,8)model for end-stage liver disease(MELD)score ≥15 on 2 consecutive occasions.
Interventions
DRUGPlacebo of BELAPECTIN
DRUGBELAPECTIN
Sponsors
Galectin Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in the belapectin treatment groups who develop esophageal varices at 78 weeks (18 months) of treatment compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop any of:1)varices (esophageal or gastric) requiring treatment,2)variceal bleed requiring hospitalization,3)clinically significant ascites requiring hospitalization,4)spontaneous bacterial peritonitis,5)overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization),6)mortality(all-cause),7)liver transplant,8)model for end-stage liver disease(MELD)score ≥15 on 2 consecutive occasions. | — |
Countries
Belgium, France, Germany, Poland, Spain
Outcome results
None listed