A Study of the Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients


  • Study type

  • Study phase

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 11-007276
    NCT ID: NCT01436500
    Sponsor Protocol Number: CPI-IFE-001

About this study

Cumberland Pharmaceuticals Inc. (CPI) is developing ifetroban for treatment of hepatorenal syndrome (HRS) and proposes to conduct a study in hospitalized adult patients with HRS to assess the safety and pharmacokinetics of escalating doses of ifetroban.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Chronic liver disease, defined as cirrhosis with ascites based on clinical findings (biopsy not necessary).
  • Subjects with either Type 1 or Type 2 renal dysfunction defined as follows
    • Type 1
      • At least a doubling of the initial serum creatinine to > 220 µmol/L (2.5 mg/dL), occurring over a period of less than 2 week
      • A 50% or greater reduction in the initial 24-hour creatinine clearance to < 20 mL/min occurring over a period of less than 2 weeks
    • Type 2
      • At least a 33% reduction in creatinine clearance occurring over a period of greater than 2 weeks, with a serum creatinine (SCr) > 133µmol/L (1.5 mg/dL)
  • Oliguria occurring within 48 hours prior to 1st administration CTM Oliguria is defined as 
    • An average urine output of < 35 mL/hr measured for at least 4 hours, occurring with a measured central venous pressure (CVP) > 12 mmHg, OR
    • In the absence of CVP monitoring, oliguria that is not corrected by a fluid challenge of at least 20mL/kg isotonic crystalloid or comparable volume of colloid.


Exclusion Criteria

  • History of allergy or hypersensitivity to ifetroban
  • Pregnant or nursing
  • Less than 18 years of age
  • Serum creatinine (SCr) > 5.0 mg/dL
  • Platelet count at screening of < 30,000/ µL
  • Active gastrointestinal hemorrhage
  • Evidence of obstructive or parenchymal renal disease 
    • Acute tubular necrosis
    • Glomerular diseases
    • Interstitial nephritis
    • Urinary obstruction
    • Lab results indicating
      • proteinuria > 500 mg/day,
      • microhematuria [> 50 RBCs/high power field],
      • abnormal renal ultrasound scanning).
  • Current or recent (within the preceding 5 days) treatment with any of the following drugs
    • aminoglycosides
    • acyclovir
    • cisplatin
    • methotrexate
    • cyclosporine
    • amphotericin B
  • Presence of shock defined as hypotension, with a mean arterial pressure less than 50 mmHG.
  • New York Heart Association class 3 or 4 heart failure.
  • Presence of hepatocellular carcinoma 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 1st CTM administration.
  • Inability to understand the requirements of the study. (Subjects must be willing to provide written informed consent or consent of legally recognized representative, as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB], and agree to abide by the study restrictions. If the subject is incapacitated, informed consent will be sought from a legally recognized representative).
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment


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