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

  • cirrhosis with ascites

  • Serum creatinine ≥ 2.0 mg/dL

  • Oliguria lasting at least 6 hours, defined as <300 mL/24 h 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; death expected within 5 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 the National Institutes of Health web page for this study. Click on the following link: