NCT02802228

Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients

A Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Safety and Efficacy of Ifetroban for the Treatment of Portal Hypertension in Cirrhotic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This placebo-controlled study will assess the safety and efficacy of a 90-day course of treatment with ifetroban for portal hypertension in cirrhotic patients

Conditions

• Portal Hypertension
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Ifetroban	thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
DRUG	Placebo	matched placebo delivered as infusion and oral capsule

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2016-06-16
• Last updated: 2022-01-19
• Results posted: 2022-01-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study