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NCT04365868 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
A Phase 2 study, sponsored by Galectin Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 357
- Enrollment target
NCT04365868: Clinical Trial Phase 2 study, sponsored by Galectin Therapeutics.
NCT04365868 is a Phase 2 study that was terminated before completion, run by Galectin Therapeutics. The registered enrollment target is 357 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365868, a Phase 2 study, was terminated before completion, sponsored by Galectin Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 357 participants
- Enrollment target
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.
Primary Outcome
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks \[18 months\] of treatment compared to placebo.
Interventions
- DRUG Placebo
- DRUG belapectin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 2 |
Why NCT04365868 stopped before completion
NCT04365868 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04365868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04365868 about?
NCT04365868 is a clinical study titled "Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis". 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...
What is the current status of trial NCT04365868?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 357 participants. The study started on 2020-06-25. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT04365868?
The interventions under investigation include: Placebo (DRUG), belapectin (DRUG).
Who is sponsoring clinical trial NCT04365868?
This trial is sponsored by Galectin Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04365868's enrollment target sits among peer trials
357 127th of 2000 higher than 1,873 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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