Page last updated: 2024-12-10

ifetroban

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

ifetroban: thromboxane receptor antagonist; structure given in first source; a 7-oxabicyclo(2.2.1)heptane derivative [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID3037233
CHEMBL ID3301673
CHEBI ID188730
SCHEMBL ID28135
MeSH IDM0211381

Synonyms (28)

Synonym
bms 180,291
gtpl1987
3-[2-[[(1s,4r,5s,6r)-5-[4-(pentylcarbamoyl)-1,3-oxazol-2-yl]-7-oxabicyclo[2.2.1]heptan-6-yl]methyl]phenyl]propanoic acid
143443-90-7
bms180291
benzenepropanoic acid, 2-((3-(4-((pentylamino)carbonyl)-2-oxazolyl)-7-oxabicyclo(2.2.1)hept-2-yl)methyl)-, (1s-(exo,exo))-
ifetroban
bms-180291
ifetroban [usan:inn]
bms 180291-02
bms 180291
o-((1s,2r,3s,4r)-3-(4-(pentylcarbamoyl)-2-oxazolyl)-7-oxabicyclo(2.2.1)hept-2-yl)methyl)hydrocinnamic acid
bdbm50212318
CHEBI:188730
3-[2-[[(1s,2r,3s,4r)-3-[4-(pentylcarbamoyl)-1,3-oxazol-2-yl]-7-oxabicyclo[2.2.1]heptan-2-yl]methyl]phenyl]propanoic acid
unii-e833kt807k
e833kt807k ,
CHEMBL3301673
SCHEMBL28135
o-[[1s,2r,3s,4r)-3-[4-(pentylcarbamoyl)-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]hydrocinnamic acid
ifetroban [inn]
ifetroban [usan]
CS-0025381
HY-105218
DB12321
DTXSID40869931
Q5991162
AKOS040748563

Research Excerpts

Overview

Ifetroban is a potent and selective thromboxane receptor antagonist.

ExcerptReferenceRelevance
"Ifetroban is a potent and selective thromboxane receptor antagonist. "( Disposition of radiolabeled ifetroban in rats, dogs, monkeys, and humans.
Barbhaiya, RH; Dockens, RC; Greene, DS; Jemal, M; Mitroka, JG; Morrison, RA; Santone, KS, 2000
)
2.04

Pharmacokinetics

ExcerptReferenceRelevance
"Human pharmacokinetic parameters are often predicted prior to clinical study from in vivo preclinical pharmacokinetic data."( Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
Jolivette, LJ; Ward, KW, 2005
)
0.33
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35

Bioavailability

ExcerptReferenceRelevance
" Absolute bioavailability was 25, 35, 23, and 48% in rats, dogs, monkeys, and humans, respectively."( Disposition of radiolabeled ifetroban in rats, dogs, monkeys, and humans.
Barbhaiya, RH; Dockens, RC; Greene, DS; Jemal, M; Mitroka, JG; Morrison, RA; Santone, KS, 2000
)
0.6

Dosage Studied

ExcerptRelevanceReference
" Dose-response curves to acetylcholine (10(-9)-10(-4) mol/l) and sodium nitroprusside (10(-9)-10(-4) mol/l) were studied in segmental arteries in the presence or absence of the thromboxane A2/PGH2 receptor antagonist ifetroban (10(-5) mol/l)."( Atorvastatin prevents glomerulosclerosis and renal endothelial dysfunction in hypercholesterolaemic rabbits.
Aragoncillo, P; Cachofeiro, V; Cediel, E; de Las Heras, N; Díaz, C; Hernández, G; Lahera, V; Navarro-Cid, J; Ruilope, LM; Sanz-Rosa, D; Vázquez-Pérez, S, 2001
)
0.5
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
monocarboxylic acidAn oxoacid containing a single carboxy group.
benzenesAny benzenoid aromatic compound consisting of the benzene skeleton and its substituted derivatives.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (17)

Assay IDTitleYearJournalArticle
AID540219Volume of distribution at steady state in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540214Clearance in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540217Volume of distribution at steady state in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540220Clearance in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540215Volume of distribution at steady state in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540216Clearance in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540230Dose normalised AUC in rat after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID540221Volume of distribution at steady state in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540231Dose normalised AUC in dog after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540218Clearance in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID540232Dose normalised AUC in monkey after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID540233Dose normalised AUC in human after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID1346422Human TP receptor (Prostanoid receptors)1993The Journal of pharmacology and experimental therapeutics, Feb, Volume: 264, Issue:2
Pharmacological profile of BMS 180,291: a potent, long-acting, orally active thromboxane A2/prostaglandin endoperoxide receptor antagonist.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (44)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's29 (65.91)18.2507
2000's11 (25.00)29.6817
2010's3 (6.82)24.3611
2020's1 (2.27)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 31.88

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index31.88 (24.57)
Research Supply Index3.89 (2.92)
Research Growth Index4.31 (4.65)
Search Engine Demand Index39.83 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (31.88)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials3 (6.67%)5.53%
Reviews2 (4.44%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other40 (88.89%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (10)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 [NCT02802228]Phase 230 participants (Actual)Interventional2017-03-06Completed
A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD) [NCT03028350]Phase 276 participants (Anticipated)Interventional2017-07-17Active, not recruiting
The Thromboxane Receptor Antagonist to Blunt the Effects of Non-Platelet Thromboxane Generation and Improve Endothelial Cell Function (TRAP) Trial [NCT03962855]Phase 252 participants (Anticipated)Interventional2019-09-20Active, not recruiting
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH) [NCT02682511]Phase 234 participants (Anticipated)Interventional2017-01-31Recruiting
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease [NCT03326063]Phase 238 participants (Actual)Interventional2018-04-26Completed
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy [NCT03340675]Phase 248 participants (Anticipated)Interventional2020-10-19Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) [NCT05571059]Phase 2128 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence [NCT03694249]Phase 260 participants (Anticipated)Interventional2018-12-12Recruiting
A Multi-Center, Double-Blind, Randomized, Controlled Study to Determine the Safety and Pharmacokinetics of Ifetroban Injection in Hepatorenal Syndrome [NCT01436500]Phase 255 participants (Actual)Interventional2011-10-31Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease [NCT02216357]Phase 219 participants (Actual)Interventional2014-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01436500 (7) [back to overview]Change in 24-hour Urine Volume
NCT01436500 (7) [back to overview]Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL
NCT01436500 (7) [back to overview]Safety: Day 28 Mortality
NCT01436500 (7) [back to overview]The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements
NCT01436500 (7) [back to overview]Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide
NCT01436500 (7) [back to overview]Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
NCT01436500 (7) [back to overview]Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
NCT02216357 (9) [back to overview]Amount of Rescue Medication Required During the Aspirin Challenge
NCT02216357 (9) [back to overview]Incidence and Severity of Asthmatic Reactions During the Treatment Period
NCT02216357 (9) [back to overview]Incidence and Severity of Treatment-emergent Adverse Events
NCT02216357 (9) [back to overview]Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge
NCT02216357 (9) [back to overview]Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
NCT02216357 (9) [back to overview]Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge
NCT02216357 (9) [back to overview]Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
NCT02216357 (9) [back to overview]Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge
NCT02216357 (9) [back to overview]Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
NCT02802228 (6) [back to overview]Alanine Aminotransferase (ALT)
NCT02802228 (6) [back to overview]Aspartate Aminotransferase/Platelet Ratio (APRI)
NCT02802228 (6) [back to overview]Change in Aspartate Aminotransferase (AST)
NCT02802228 (6) [back to overview]Change in Hepatic Venous Pressure Gradient (HVPG)
NCT02802228 (6) [back to overview]Safety (Incidence and Severity of Adverse Events)
NCT02802228 (6) [back to overview]Variceal Bleeds (Occurrence of Variceal Bleeds)
NCT03326063 (7) [back to overview]Aspirin-induced Leukotriene E4 (LTE4) Levels
NCT03326063 (7) [back to overview]Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score
NCT03326063 (7) [back to overview]Change in Chronic Disease Control by Measurement of Lung Function Through FEV1
NCT03326063 (7) [back to overview]Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score
NCT03326063 (7) [back to overview]Fractional Exhaled Nitric Oxide (FeNO)
NCT03326063 (7) [back to overview]Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)
NCT03326063 (7) [back to overview]Provocative Dose 2 (PD2) During Aspirin Challenge

Change in 24-hour Urine Volume

The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period. (NCT01436500)
Timeframe: Baseline to Hour 96

InterventionmL (Mean)
Ifetroban Injection267.3
Placebo-118.5

[back to top]

Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL

(NCT01436500)
Timeframe: Day 0 through Day 5

Interventionpercentage of participants (Number)
Ifetroban Injection21
Placebo15

[back to top]

Safety: Day 28 Mortality

(NCT01436500)
Timeframe: 28 days

Interventionpercentage of participants (Number)
Ifetroban Injection17
Placebo15

[back to top]

The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements

(NCT01436500)
Timeframe: Day 0 to Day 5

Interventionpercentage of participants (Number)
Ifetroban Injection62
Placebo77

[back to top]

Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide

Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters. (NCT01436500)
Timeframe: 3 days

,,,,,,
Interventionhours (Mean)
half-life ifetrobanhalf-life ifetroban acylglucuronide
15 mg Ifetroban, Type 115.722.1
15 mg Ifetroban, Type 210.518.6
150 mg Ifetroban, Type 217.412.6
5 mg Ifetroban, Type 136.017.1
5 mg Ifetroban, Type 211.914.7
50 mg Ifetroban, Type 118.126.4
50 mg Ifetroban, Type 213.515.2

[back to top]

Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment

Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters. (NCT01436500)
Timeframe: 3 days

,,,,,,
Interventionng/mL (Mean)
Minimum Concentration IfetrobanMaximum Concentration IfetrobanMinimum Concentration Ifetroban AcylglucuronideMaximum Concentration Ifetroban Acylglucuronide
15 mg Ifetroban, Type 114.1581241.9912
15 mg Ifetroban, Type 223.5785200.21214
150 mg Ifetroban, Type 2150.067901755.010447
5 mg Ifetroban, Type 11.848378.4384
5 mg Ifetroban, Type 23.425141.4448
50 mg Ifetroban, Type 143.31666778.04737
50 mg Ifetroban, Type 251.12599632.94666

[back to top]

Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment

Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters. (NCT01436500)
Timeframe: 3 days

,,,,,,
Interventionng*hr/mL (Mean)
Ifetroban area under the curve (AUC) to 24 hoursIfetroban AUC to infinityIfetroban acylglucuronide AUC to 24 hours toIfetroban acylglucuronide AUC to infinity
15 mg Ifetroban, Type 1202529591219221962
15 mg Ifetroban, Type 2246332591203829857
150 mg Ifetroban, Type 21861224657109915144951
5 mg Ifetroban, Type 1964247643718440
5 mg Ifetroban, Type 277990641456128
50 mg Ifetroban, Type 1515165054645586457
50 mg Ifetroban, Type 2663482044205161673

[back to top]

Amount of Rescue Medication Required During the Aspirin Challenge

The amount of rescue medication required during the aspirin challenge (NCT02216357)
Timeframe: Study Day 2 and 3

Interventionnumber of rescue medications (Mean)
Ifetroban, Oral Capsule2.9
Placebo, Oral Capsule7.33

[back to top]

Incidence and Severity of Asthmatic Reactions During the Treatment Period

(NCT02216357)
Timeframe: Study Day 1 through 3

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule0
Placebo, Oral Capsule0

[back to top]

Incidence and Severity of Treatment-emergent Adverse Events

(NCT02216357)
Timeframe: Up to Study Day 7

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule11
Placebo, Oral Capsule4

[back to top]

Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge

(NCT02216357)
Timeframe: Study Day 2 and 3

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule0
Placebo, Oral Capsule0

[back to top]

Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge

(NCT02216357)
Timeframe: Study Day 2

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule0
Placebo, Oral Capsule0

[back to top]

Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge

(NCT02216357)
Timeframe: Study Day 2 and 3

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule4
Placebo, Oral Capsule1

[back to top]

Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge

(NCT02216357)
Timeframe: Up to Study Day 2

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule2
Placebo, Oral Capsule1

[back to top]

Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge

(NCT02216357)
Timeframe: Study Day 2 and 3

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule3
Placebo, Oral Capsule1

[back to top]

Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge

(NCT02216357)
Timeframe: Up to Study Day 2

InterventionParticipants (Count of Participants)
Ifetroban, Oral Capsule0
Placebo, Oral Capsule0

[back to top]

Alanine Aminotransferase (ALT)

ALT values through Day 90 will be compared to baseline (NCT02802228)
Timeframe: Baseline and 90 days

InterventionU/L (Mean)
Ifetroban-4.8
Placebo2.2

[back to top]

Aspartate Aminotransferase/Platelet Ratio (APRI)

The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline (NCT02802228)
Timeframe: Baseline and 90 days

Interventionratio (Mean)
Ifetroban0.84
Placebo0.98

[back to top]

Change in Aspartate Aminotransferase (AST)

AST values through Day 90 will be compared to baseline (NCT02802228)
Timeframe: Baseline and 90 days

InterventionU/L (Mean)
Ifetroban-1.2
Placebo4.2

[back to top]

Change in Hepatic Venous Pressure Gradient (HVPG)

The HVPG will be measured through Day 90 and will be compared to baseline (NCT02802228)
Timeframe: Baseline and 90 days

InterventionmmHg (Mean)
Ifetroban1.6
Placebo-0.1

[back to top]

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. (NCT02802228)
Timeframe: Through 97 days (90 days treatment and 7 days follow-up)

InterventionNumber of adverse events (Number)
Ifetroban23
Placebo2

[back to top]

Variceal Bleeds (Occurrence of Variceal Bleeds)

The number of variceal bleeds during the treatment and follow-up periods will be evaluated (NCT02802228)
Timeframe: Through Day 97

Interventionevents of variceal bleeding (Number)
Ifetroban0
Placebo1

[back to top]

Aspirin-induced Leukotriene E4 (LTE4) Levels

Increase of urinary levels of LTE4 during aspirin-induced reaction from Visit 2 pre-aspirin levels, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. LTE4 levels were calculated in a specialized laboratory. (NCT03326063)
Timeframe: Visit 2. The change in LTE4 levels from the morning baseline to the aspirin-induced highest value in LTE4 during reaction to aspirin challenge that same day.

Interventionng/mg creatinine (Mean)
Ifetroban0.72
Placebo0.15

[back to top]

Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score

"Change from Visit 1 in baseline ACQ (Asthma Control Questionnaire) score, compared between patients on placebo vs ifetroban.~ACQ is a patient-reported questionnaire measurement of asthma control from 0-6, where lower scores suggest better asthma control. The score is the average result of the answer choices picked by the patient." (NCT03326063)
Timeframe: 1 month (between Visit 1 and Visit 2)

Interventionscores on a scale (Mean)
Ifetroban0.17
Placebo-0.03

[back to top]

Change in Chronic Disease Control by Measurement of Lung Function Through FEV1

Change from Visit 1 in baseline FEV1,compared between patients on placebo vs ifetroban. (NCT03326063)
Timeframe: 1 month (between Visit 1 and Visit 2)

Interventionpercent change from baseline (Mean)
Ifetroban-0.2
Placebo-0.5

[back to top]

Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score

"Change from Visit 1 in baseline SNOT-22 score at Visit 2, compared between patients on placebo vs ifetroban.~The SNOT-22 is a patient-reported questionnaire with a summed scale that goes from 0-110 and a lower score suggests better sinonasal control." (NCT03326063)
Timeframe: 1 month (between Visit 1 and Visit 2)

Interventionscores on a scale (Mean)
Ifetroban1.5
Placebo-2.0

[back to top]

Fractional Exhaled Nitric Oxide (FeNO)

Change from Visit 1 in baseline FeNO levels at Visit 2, compared between patients on placebo vs ifetroban. (NCT03326063)
Timeframe: 1 month (between Visit 1 and Visit 2)

Interventionparts per billion (Mean)
Ifetroban7.9
Placebo-3.4

[back to top]

Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)

Severity of bronchoconstriction during the aspirin-induced reaction at Visit 2, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. Measured by an aspirin-induced decrease in FEV1. (NCT03326063)
Timeframe: At Visit 2. The change in FEV1 from the morning baseline to the aspirin-induced lowest value in FEV1 during reaction to aspirin challenge later that same day.

Interventionpercentage change from baseline (Mean)
Ifetroban-18.8
Placebo-8.4

[back to top]

Provocative Dose 2 (PD2) During Aspirin Challenge

"The calculated dose of aspirin that induces an increase in the Total Nasal Symptom Score (TNSS) of 2 from the pre-aspirin challenge value, PD2~TNSS: A higher TNSS score suggests more severe symptoms, on a scale from 0-65 PD2: A higher PD2 suggests that the patient's threshold of reactivity of aspirin was higher" (NCT03326063)
Timeframe: 6 weeks from screening visit ( at visit 2)

Interventionmg (Mean)
Ifetroban121
Placebo142

[back to top]