Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
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
1 other identifier
interventional
30
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2017
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2018
CompletedResults Posted
Study results publicly available
January 19, 2022
CompletedJanuary 19, 2022
January 1, 2021
1.4 years
June 9, 2016
January 29, 2021
January 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (5)
Change in Hepatic Venous Pressure Gradient (HVPG)
Baseline and 90 days
Change in Aspartate Aminotransferase (AST)
Baseline and 90 days
Alanine Aminotransferase (ALT)
Baseline and 90 days
Aspartate Aminotransferase/Platelet Ratio (APRI)
Baseline and 90 days
Variceal Bleeds (Occurrence of Variceal Bleeds)
Through Day 97
Study Arms (2)
Ifetroban
EXPERIMENTAL90 day course of oral ifetroban following intravenous loading dose
Placebo
PLACEBO COMPARATOR90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Interventions
Eligibility Criteria
You may qualify if:
- liver cirrhosis
- baseline hepatic venous pressure gradient (HVPG) \>= 8 mmHg and \<= 18 mmHg
- stable liver function enzymes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Tampa General Medical Group
Tampa, Florida, 33606, United States
Indiana University
Indianapolis, Indiana, 46202, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jerry Fox, DVM
- Organization
- Cumberland Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Don Rockey, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 16, 2016
Study Start
March 6, 2017
Primary Completion
July 17, 2018
Study Completion
July 17, 2018
Last Updated
January 19, 2022
Results First Posted
January 19, 2022
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share