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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Gastrointestinal
Therapuetic Areas:	Cardiology / Vascular Diseases, Gastroenterology
Healthy:	No
Age Range:	18 - 70
Updated:	8/18/2018
Start Date:	March 6, 2017
End Date:	July 23, 2018

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

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

Inclusion Criteria:

- liver cirrhosis

- baseline HVPG >= 8 mmHg and <= 18 mmHg

- stable liver function enzymes

Exclusion Criteria:

- portal or splenic vein thrombosis

- TIPS or portocaval shunt

- variceal bleed in last 2 months

- hemodialysis

- Child-Pugh Score >= 12

- MELD-Na >= 20

- Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL

- current alcohol consumption > 2 drinks per day

- PLT < 60 x 10^3/uL

- A change in statin therapy in the last 3 months

- Current HBV or HCV therapy; or planned initiation of therapy during the treatment
period

- Myocardial infarction within 30 days

- History of bleeding diathesis or current (within previous 14 days) or planned use of
anticoagulant or antiplatelet drugs including aspirin

We found this trial at

sites

Tampa General Medical Group

Tampa, Florida 33606

from

Tampa, FL