drugset / Trial / NCT04365868
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2020-06-25
- Primary completion
- 2025-03-11
- Completion
- 2025-04-10
Outcome
Outcome not reported
Stopped: “Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | belapectin | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | belapectin | Other / unclassified | 4 mg/kg | Intravenous |