Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
NCT ID: NCT01436500
Last Updated: 2017-03-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2011-10-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
NCT06736223
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
NCT01157104
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
NCT02121860
Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
NCT04020016
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
NCT02474537
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
5 mg ifetroban, Type 1
60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
Placebo, Type 1
60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS.
Placebo
Sterile water with 5% Dextrose
5 mg ifetroban, Type 2
60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
15 mg ifetroban, Type 1
60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
15 mg ifetroban, Type 2
60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
50 mg ifetroban, Type 1
60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
50 mg ifetroban, Type 2
60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
150 mg ifetroban, Type 2
60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
Placebo, Type 2
60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.
Placebo
Sterile water with 5% Dextrose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ifetroban Injection
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
Placebo
Sterile water with 5% Dextrose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with either Type 1 or Type 2 HRS defined in a and b below:
a. Type 1: i. At least a doubling of the serum creatinine to a minimum of 220 µmol/L (2.5 mg/dL) at enrollment, occurring over a period of less than 14 days, OR ii. A 50% or greater reduction in the estimated glomerular filtration rate (GFR - calculated by the method of Cockcroft-Gault) to below 20 mL/min at enrollment occurring over a period of less than 14 days.
iii. A projected doubling of serum creatinine to a minimum of 2.5 mg/dL, expected to occur in less than 14 days based on the rate of change observed.
b. Type 2: defined as 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).
3. Oliguria occurring within 48 hours prior to the first administration CTM. Oliguria is defined as an average urine output of \< 35 mL/hr (measured for a minimum of 4 hours) under either of the following circumstances:
a. When measured central venous pressure (CVP) \> 12 mmHg, OR b. following a fluid challenge consisting of either: i. at minimum 20 mL/kg isotonic fluid (e.g. any combination of 5% albumin, normal saline, blood or blood products) given over no more than 6 hours ii. at minimum 1 g/kg of hypertonic fluid (e.g. 25% albumin) given over no more than 24 hours iii. an equivalent combination of 3.b.i and 3.b.ii
Exclusion Criteria
2. Pregnant or nursing
3. Less than 18 years of age
4. Serum creatinine at the time of enrollment greater than or equal to 5.0 mg/dL
5. Platelet count at screening less than 30 x 10\^3 platelets/µL
6. Anticipated of planned need for dialysis within 5 days of first CTM dose.
7. Active gastrointestinal hemorrhage (where active is defined as evidence of bleeding within 48 hours of the first dose of CTM)
8. Evidence of current (within past 30 days) obstructive (post-renal) or intrinsic renal disease \[including but not limited to: acute tubular necrosis (ATN), glomerular diseases/glomerulonephritis, acute interstitial nephritis (AIN), known urinary obstruction, proteinuria \> 500 mg/day, microhematuria (\> 50 RBCs/high power field), abnormal renal ultrasound, fractional excretion of sodium (FeNa) \> 2.0%, any urinary casts other than hyaline.
9. Current or recent (within the preceding 5 days) treatment with nephrotoxic drugs including but not limited to: NSAIDs (prior 48 hours), angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), calcineurin inhibitors (cyclosporine, tacrolimus), aminoglycosides, amphotericin B, antiretrovirals and antivirals (adefovir, cidofovir, tenofovir, acyclovir, indinavir), cisplatin, methotrexate, cyclosporine, amphotericin B contrast agents, foscarnet, zoledronate, etc.
10. Presence of shock defined as hypotension, with a mean arterial pressure less than 50 mmHG.
11. New York Heart Association class 3 or 4 heart failure.
12. Presence of hepatocellular carcinoma not transplantable by Milan criteria
13. Cardiopulmonary arrest without full recovery of mental status
14. Moribund and death expected within five days
15. Bacterial or fungal infections which have been unresponsive to at least 24 hours of appropriate antimicrobial therapy
16. Burns \> 30% body surface area
17. Exposed to investigational drugs within 30 days before 1st CTM administration.
18. 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).
19. Refusal to provide written authorization for use and disclosure of protected health information.
20. Be otherwise unsuitable for the study, in the opinion of the Investigator.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brendan McGuire, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic - Arizona
Phoenix, Arizona, United States
UCSD, Hillcrest Medical Center Hospital
La Jolla, California, United States
UCSF (University of California-San Francisco)
San Francisco, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Indiana University (Division of Gastroenterology/Hepatology)
Indianapolis, Indiana, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
NYU Langone Medical Center
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
MIDAS Multispeciality Hospital PVT LTD
Nagpur, Maharashtra, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CPI-IFE-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.