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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02802228
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : April 17, 2018
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)
Estimated 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02802228

Contact: Jerry Fox, DVM 6152550068

United States, Florida
Tampa General Medical Group Recruiting
Tampa, Florida, United States, 33606
Contact: Michele Reilly         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Nina Garrett         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Angela Sipes         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Linsay Totin         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Tanya Narithookil         
United States, Utah
University of Utah Withdrawn
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23114
Contact: Stephanie Taylor         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Principal Investigator: Don Rockey, MD Medical University of South Carolina

Responsible Party: Cumberland Pharmaceuticals Identifier: NCT02802228     History of Changes
Other Study ID Numbers: CPI-IFE-005
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 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:
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Platelet Aggregation Inhibitors