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Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

NCT04365868 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Prevention of Esophageal Varices
  • NASH - Nonalcoholic Steatohepatitis
  • Cirrhosis

Interventions

DRUG

belapectin

intravenous

DRUG

Placebo

intravenous

Sponsors & Collaborators

  • Galectin Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Khurram Jamil, M.D. · Galectin Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2025-03-11
Completion
2025-04-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • France
  • Germany
  • Israel
  • Mexico
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365868 on ClinicalTrials.gov