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Thromboxane A2 Receptor Antagonist

15 mg ifetroban, Type 2 for Hepatorenal Syndrome

Phase 2
Waitlist Available
Led By Brendan McGuire, MD
Research Sponsored by Cumberland Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to hour 96

Summary

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.

Eligible Conditions
  • Hepatorenal Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to hour 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to hour 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide
Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Secondary study objectives
Change in 24-hour Urine Volume

Side effects data

From 2015 Phase 2 trial • 55 Patients • NCT01436500
12%
Dyspnoea
10%
abdominal pain
7%
hypotension
7%
chronic hepatic failure
7%
atrial fibrillation
7%
nausea
7%
anaemia
5%
peritoneal haemorrhage
5%
dyspnoea
2%
Renal failure chronic
2%
respiratory failure
2%
Atrial fibrillation
2%
deep vein thrombosis
2%
worsening renal function
2%
device failure
2%
liver disorder
2%
bacteraemia
2%
complications of transplanted liver
2%
post procedural haematoma
2%
peritonitis bacterial
2%
renal failure
2%
hypoxia
2%
catheter site haemorrhage
2%
haematemesis
2%
haematochezia
2%
shock haemorrhagic
2%
upper gastrointestinal haemorrhage
2%
hyperkalaemia
2%
Bradycardia
2%
hepatorenal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ifetroban
Placebo

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg ifetroban, Type 2Experimental Treatment1 Intervention
60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Group II: 50 mg ifetroban, Type 1Experimental Treatment1 Intervention
60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Group III: 5 mg ifetroban, Type 2Experimental Treatment1 Intervention
60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Group IV: 5 mg ifetroban, Type 1Experimental Treatment1 Intervention
60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Group V: 150 mg ifetroban, Type 2Experimental Treatment1 Intervention
60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Group VI: 15 mg ifetroban, Type 2Experimental Treatment1 Intervention
60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Group VII: 15 mg ifetroban, Type 1Experimental Treatment1 Intervention
60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Group VIII: Placebo, Type 2Placebo Group1 Intervention
60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.
Group IX: Placebo, Type 1Placebo Group1 Intervention
60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ifetroban
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
9,386 Total Patients Enrolled
Brendan McGuire, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
150 Total Patients Enrolled
~4 spots leftby Nov 2025
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