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

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ClinicalTrials.gov Identifier: NCT02802228
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Portal Hypertension Liver Cirrhosis Drug: Ifetroban Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ifetroban
90 day course of oral ifetroban following intravenous loading dose
Drug: Ifetroban
thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule

Placebo Comparator: Placebo
90 day course of placebo following intravenous dose of D5W
Drug: Placebo
matched placebo delivered as infusion and oral capsule




Primary Outcome Measures :
  1. Safety (incidence and severity of adverse events) [ Time Frame: Through 97 days ]
    safety will be assessed by the incidence and severity of adverse events


Secondary Outcome Measures :
  1. 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. 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. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802228


Locations
United States, Florida
Tampa General Medical Group
Tampa, Florida, United States, 33606
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23114
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Don Rockey, MD Medical University of South Carolina

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02802228     History of Changes
Other Study ID Numbers: CPI-IFE-005
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Ifetroban
Platelet Aggregation Inhibitors