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).

Clinical Trial Conditions for Ifetroban

Condition Name

Condition Name for
Intervention	Trials
Asthma, Aspirin-Induced	2
Limited Stage Small Cell Lung Carcinoma	1
Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma	1
Anatomic Stage IIIB Breast Cancer	1

Condition MeSH

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

Clinical Trial Locations for Ifetroban

Trials by Country

Trials by Country for
Location	Trials
United States	57
India	3

Trials by US State

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

Clinical Trial Progress for Ifetroban

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	10

Clinical Trial Status

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

Clinical Trial Sponsors for Ifetroban

Sponsor Name

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

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	9
Other	5