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NCT Number: NCT02802228

Study to Assess Safety and Efficacy of Ifetroban for 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

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Key information

Conditions

Portal Hypertension Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tampa General Medical Group, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ifetroban

Drug

thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule

Placebo

Drug

matched placebo delivered as infusion and oral capsule

Primary outcomes

  1. Safety (Incidence and Severity of Adverse Events)

    Time frame: Through 97 days (90 days treatment and 7 days follow-up)

    Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.

  2. Safety (Severity of Adverse Events)

    Time frame: Through 90 days treatment and 7 days follow-up

    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.

Secondary outcomes

  1. Change in Hepatic Venous Pressure Gradient (HVPG)

    Time frame: Baseline and 90 days

    The HVPG will be measured through Day 90 and will be compared to baseline

  2. Change in Aspartate Aminotransferase (AST)

    Time frame: Baseline and 90 days

    AST values through Day 90 will be compared to baseline

  3. Alanine Aminotransferase (ALT)

    Time frame: Baseline and 90 days

    ALT values through Day 90 will be compared to baseline

  4. Aspartate Aminotransferase/Platelet Ratio (APRI)

    Time frame: Baseline and 90 days

    The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline

  5. Variceal Bleeds (Occurrence of Variceal Bleeds)

    Time frame: Through Day 97

    The number of variceal bleeds during the treatment and follow-up periods will be evaluated

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2016
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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