Hepatorenal Syndrome
printer friendly version
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 |
-
Cirrhosis with ascites
-
Serum creatinine ≥ 2.0 mg/dL
-
Oliguria lasting at least six hours, defined as < 300 mL/24h urinary output
-
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
|
-
History of allergy or hypersensitivity to ifetroban
-
Pregnant or nursing
-
Age < 18 years
-
SCr > 5.0 mg/dL
-
Platelet count at screening of <30,000
-
Active gastrointestinal hemorrhage
-
Evidence of obstructive or parenchymal renal disease
-
NYHA class 3 or 4 heart failure
-
Presence of HCC not transplantable by Milan criteria
-
Cardiopulmonary arrest without full recovery of mental status
-
Moribund and death expected within five days
-
Uncontrolled bacterial or fungal infections, defined as receiving appropriate antimicrobial therapy for > 24 hours
-
Burns > 30% body surface area
-
Exposed to investigational drugs within 30 days before CTM administration.
-
Inability to understand the requirements of the study.
-
Refusal to provide written authorization for use and disclosure of protected health information.
-
Be otherwise unsuitable for the study, in the opinion of the Investigator
|
Contact persons
For more information visit
http://clinicaltrials.gov/ct2/show/NCT01436500