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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-07-17

Brief Summary

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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

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Detailed Description

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Conditions

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Portal Hypertension Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ifetroban

90 day course of oral ifetroban following intravenous loading dose

Group Type EXPERIMENTAL

Ifetroban

Intervention Type DRUG

thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule

Placebo

90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matched placebo delivered as infusion and oral capsule

Interventions

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Ifetroban

thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule

Intervention Type DRUG

Placebo

matched placebo delivered as infusion and oral capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No