CLINICAL TRIALS PROFILE FOR IFETROBAN

Clinical Trials for Ifetroban

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01436500 ↗	Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients	Completed	Cumberland Pharmaceuticals	Phase 2	A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.
NCT02216357 ↗	Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease	Completed	Cumberland Pharmaceuticals	Phase 2	The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.
NCT02682511 ↗	Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension	Recruiting	Cumberland Pharmaceuticals	Phase 2	The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
NCT02802228 ↗	Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients	Completed	Cumberland Pharmaceuticals	Phase 2	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
NCT03028350 ↗	Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)	Recruiting	Cumberland Pharmaceuticals	Phase 2	The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.
NCT03326063 ↗	Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban	Recruiting	Brigham and Women's Hospital	Phase 2	The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).
NCT03340675 ↗	Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy	Recruiting	Vanderbilt University Medical Center	Phase 2	Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and inevitably premature death of affected young men in their late twenties. DMD is the most common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every 3,500 live male births across all races and cultures, and results in 20,000 new cases each year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause of death. As there are yet no specific cardiac treatments to extend life, the current study aims to address this unmet medical need using a new therapeutic strategy for patients with DMD. Funding Source - FDA OOPD

Clinical Trial Conditions for Ifetroban

Condition Name

Condition Name
Intervention	Trials
Asthma, Aspirin-Induced	2
HER2/Neu Negative	1
Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma	1
Anatomic Stage III Breast Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Respiratory Tract Diseases	3
Respiration Disorders	3
Hypertension	2
Asthma, Aspirin-Induced	2

Clinical Trial Locations for Ifetroban

Trials by Country

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Trials by Country
Location	Trials
United States	57
India	3

Trials by US State

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−

Trials by US State
Location	Trials
California	5
Texas	4
Ohio	4
New York	4
Indiana	4

Clinical Trial Progress for Ifetroban

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	10

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	6
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for Ifetroban

Sponsor Name

Sponsor Name
Sponsor	Trials
Cumberland Pharmaceuticals	9
Brigham and Women's Hospital	1
Vanderbilt University Medical Center	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	9
Other	5