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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802228
• Other study ID #: CPI-IFE-005
• Status: Completed
• Phase: Phase 2
• Start date: March 6, 2017
• Est. completion date: July 17, 2018

Study information

• Verified date: January 2021
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Ifetroban
thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
• Placebo
matched placebo delivered as infusion and oral capsule

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Tampa General Medical Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Incidence and Severity of Adverse Events)	Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.	Through 97 days (90 days treatment and 7 days follow-up)
Primary	Safety (Severity of Adverse Events)	The severity of each event is reported by the investigator according to the following protocol/CTCAE definitions: Grade 1-Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2-Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3-Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4-Life-threatening consequences; urgent intervention indicated; Grade 5-Death related to adverse event.	Through 90 days treatment and 7 days follow-up
Secondary	Change in Hepatic Venous Pressure Gradient (HVPG)	The HVPG will be measured through Day 90 and will be compared to baseline	Baseline and 90 days
Secondary	Change in Aspartate Aminotransferase (AST)	AST values through Day 90 will be compared to baseline	Baseline and 90 days
Secondary	Alanine Aminotransferase (ALT)	ALT values through Day 90 will be compared to baseline	Baseline and 90 days
Secondary	Aspartate Aminotransferase/Platelet Ratio (APRI)	The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline	Baseline and 90 days
Secondary	Variceal Bleeds (Occurrence of Variceal Bleeds)	The number of variceal bleeds during the treatment and follow-up periods will be evaluated	Through Day 97