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Hepatorenal Syndrome

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Safety and pharmacokinetics of ifetroban in hepatorenal syndrome patients

 

Enrollment Status: OPEN

 

Primary objectives

Secondary objective

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