Hepatorenal Syndrome
Safety and pharmacokinetics of ifetroban in hepatorenal syndrome patients
Enrollment Status: OPEN
Primary objectives
- To determine the pharmacokinetic profile of multiple daily intravenous doses of ifetroban and its major metabolite ifetroban acylglucuronide
- To determine the tolerability and safety of ifetroban injection in patients with HRS.
Secondary objective
- To determine if ifetroban changes renal function, showing evidence of HRS reversal.
Study design
Phase 2a prospective multi-center double-blind randomized controlled study
Inclusion criteria |
Exclusion criteria |
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cirrhosis with ascites
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Serum creatinine ≥2.0 mg/dL
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Oliguria lasting at least 6 hours, defined as <300 mL/24 h urinary output
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Unresponsive to fluid challenge of 1.5 L NS with or without albumin within the previous 48 hours or documented central venous pressure (CVP) > 12
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History of allergy or hypersensitivity to ifetroban
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Pregnant or nursing
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Age < 18 years
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SCr > 5.0 mg/dL
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Platelet count at screening of <30,000
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Active gastrointestinal hemorrhage
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Evidence of obstructive or parenchymal renal disease
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NYHA class 3 or 4 heart failure
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Presence of HCC not transplantable by Milan criteria
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Cardiopulmonary arrest without full recovery of mental status
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Moribund; death expected within 5 days
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Uncontrolled bacterial or fungal infections, defined as receiving appropriate antimicrobial therapy for >24 hours
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Burns >30% body surface area
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Exposed to investigational drugs within 30 days before CTM administration.
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Inability to understand the requirements of the study.
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Refusal to provide written authorization for use and disclosure of protected health information.
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Be otherwise unsuitable for the study, in the opinion of the investigator
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Contact persons
For more information
Visit the National Institutes of Health web page for this study. Click on the following link:
http://clinicaltrials.gov/ct2/show/NCT01436500