Clinical trial NCT02802228: Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Portal Hypertension
Liver Cirrhosis
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* baseline hepatic venous pressure gradient (HVPG) \>= 8 mmHg and \<= 18 mmHg
* stable liver function enzymes

Exclusion Criteria:

* portal or splenic vein thrombosis
* Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt
* variceal bleed in last 2 months
* hemodialysis
* Child-Pugh Score \>= 12
* Model for End-stage Liver Disease- Sodium score (MELD-Na) \>= 20
* Acute kidney injury, Chronic kidney disease and/or Serum Creatinine \>= 2.0 mg/dL
* current alcohol consumption \> 2 drinks per day
* Platelet count (PLT) \< 60 x 10\^3/microliter (uL)
* A change in statin therapy in the last 3 months
* Current Hepatitis Virus B or C (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

Primary outcomes:
measure: Safety (Incidence and Severity of Adverse Events)
timeFrame: Through 97 days (90 days treatment and 7 days follow-up)
measure: Safety (Severity of Adverse Events)
timeFrame: Through 90 days treatment and 7 days follow-up
Secondary outcomes:
measure: Change in Hepatic Venous Pressure Gradient (HVPG)
timeFrame: Baseline and 90 days
measure: Change in Aspartate Aminotransferase (AST)
timeFrame: Baseline and 90 days
measure: Alanine Aminotransferase (ALT)
timeFrame: Baseline and 90 days
measure: Aspartate Aminotransferase/Platelet Ratio (APRI)
timeFrame: Baseline and 90 days
measure: Variceal Bleeds (Occurrence of Variceal Bleeds)
timeFrame: Through Day 97
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Medical University of South Carolina
name: Don Rockey, MD
role: PRINCIPAL_INVESTIGATOR
References: