Hepatorenal SyndromePhase 2NCT01436500

Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients

A Phase 2 study testing Ifetroban Injection in people with Hepatorenal Syndrome, run by Cumberland Pharmaceuticals at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatorenal Syndrome
What is being tested?: Ifetroban Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 12 sitesin 2 countries
Study dates: Oct 2011to Jul 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic liver disease, defined as cirrhosis with ascites based on clinical findings (biopsy not necessary).
Subjects with either Type 1 or Type 2 HRS defined in a and b below:
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.
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.
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).
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:
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

Who cannot join

History of allergy or hypersensitivity to ifetroban
Pregnant or nursing
Less than 18 years of age
Serum creatinine at the time of enrollment greater than or equal to 5.0 mg/dL
Platelet count at screening less than 30 x 10^3 platelets/µL
Anticipated of planned need for dialysis within 5 days of first CTM dose.

Show all 20Show fewer

Active gastrointestinal hemorrhage (where active is defined as evidence of bleeding within 48 hours of the first dose of CTM)
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.
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.
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
Bacterial or fungal infections which have been unresponsive to at least 24 hours of appropriate antimicrobial therapy
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.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States11 sites

University of Michigan Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
The Ohio State University
Columbus, Ohio, 43210
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
Indiana University (Division of Gastroenterology/Hepatology)
Indianapolis, Indiana, 46202
UCSD, Hillcrest Medical Center Hospital
La Jolla, California, 92093
NYU Langone Medical Center
New York, New York, 10016
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
UCSF (University of California-San Francisco)
San Francisco, California, 94143

Other trials in United States

India1 site

MIDAS Multispeciality Hospital PVT LTD
Nagpur, Maharashtra, 440010

Other trials in India

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Controlled Study to Determine the Safety and Pharmacokinetics of Ifetroban Injection in Hepatorenal Syndrome

A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.

Conditions: Hepatorenal Syndrome
Being tested: Ifetroban Injection, Placebo
Keywords: Hepatorenal Syndrome, HRS, ifetroban
Medical subject headings: Hepatorenal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ifetroban InjectionDrug
Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
PlaceboDrug
Also called D5W
Sterile water with 5% Dextrose

Study groups in NCT01436500
Study group	Role	What they receive
5 mg ifetroban, Type 1	Experimental	60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. Receives: Drug: Ifetroban Injection
Placebo, Type 1	Placebo comparator	60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS. Receives: Drug: Placebo
5 mg ifetroban, Type 2	Experimental	60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. Receives: Drug: Ifetroban Injection
15 mg ifetroban, Type 1	Experimental	60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. Receives: Drug: Ifetroban Injection
15 mg ifetroban, Type 2	Experimental	60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. Receives: Drug: Ifetroban Injection
50 mg ifetroban, Type 1	Experimental	60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. Receives: Drug: Ifetroban Injection
50 mg ifetroban, Type 2	Experimental	60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. Receives: Drug: Ifetroban Injection
150 mg ifetroban, Type 2	Experimental	60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. Receives: Drug: Ifetroban Injection
Placebo, Type 2	Placebo comparator	60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide
Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Measured: 3 days
Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Measured: 3 days
Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Measured: 3 days

Secondary outcomes (4)

Safety: Day 28 Mortality
Measured: 28 days
Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL
Measured: Day 0 through Day 5
The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements
Measured: Day 0 to Day 5
Change in 24-hour Urine Volume
The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period.
Measured: Baseline to Hour 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jul 2015

First posted19 Sep 2011 (estimated)
Study startOct 2011
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01436500
Sponsor's protocol ID: CPI-IFE-001
Status last verified: Feb 2017
First submitted: 31 Aug 2011
Last updated: 1 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I
RecruitingObservational study
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis, Acute Kidney Injury Due to Sepsis
RecruitingObservational study
A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center
Hepatorenal Syndrome
Active, not recruitingPhase 2
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Recruiting
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All Hepatorenal Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Blind, Randomized, Controlled Study to Determine the Safety and Pharmacokinetics of Ifetroban Injection in Hepatorenal Syndrome
ClinicalTrials.gov ID: NCT01436500
Acronym / sponsor ID: CPI-IFE-001
Conditions: Hepatorenal Syndrome
Keywords: Hepatorenal Syndrome, HRS, ifetroban
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 19 Sep 2011 (estimated)
Results: Posted 14 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
5 mg ifetroban, Type 1	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Placebo, Type 1	Placebo comparator	Drug: Placebo60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS.
5 mg ifetroban, Type 2	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
15 mg ifetroban, Type 1	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
15 mg ifetroban, Type 2	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
50 mg ifetroban, Type 1	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
50 mg ifetroban, Type 2	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
150 mg ifetroban, Type 2	Experimental	Drug: Ifetroban Injection60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Placebo, Type 2	Placebo comparator	Drug: Placebo60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chronic liver disease, defined as cirrhosis with ascites based on clinical findings (biopsy not necessary).
Subjects with either Type 1 or Type 2 HRS defined in a and b below:
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:

Key exclusion criteria (20 listed)

History of allergy or hypersensitivity to ifetroban
Pregnant or nursing
Less than 18 years of age
Serum creatinine at the time of enrollment greater than or equal to 5.0 mg/dL
Platelet count at screening less than 30 x 10^3 platelets/µL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ifetroban InjectionIfetroban sodium injectable, diluted in sterile water with 5% dextrose	Drug	15 mg ifetroban, Type 1, 15 mg ifetroban, Type 2, 150 mg ifetroban, Type 2, 5 mg ifetroban, Type 1, 5 mg ifetroban, Type 2, 50 mg ifetroban, Type 1, 50 mg ifetroban, Type 2
PlaceboAlso: D5WSterile water with 5% Dextrose	Drug	Placebo, Type 1, Placebo, Type 2

Primary outcome

Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide
Time frame: 3 days
Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Time frame: 3 days
Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
Time frame: 3 days
Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.

4 secondary outcomes

Safety: Day 28 Mortality
Time frame: 28 days
Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL
Time frame: Day 0 through Day 5
The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements
Time frame: Day 0 to Day 5
Change in 24-hour Urine Volume
Time frame: Baseline to Hour 96

Results and safety

Results posted to the registry on 14 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 mg Ifetroban	12	9
15 mg Ifetroban	12	9
50 mg Ifetroban	12	7
150 mg Ifetroban	6	5
Placebo	13	9

Primary outcome: Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide

Time frame: 3 days. Mean (Standard Deviation). Unit: hours

Measure	5 mg Ifetroban, Type 1 n = 5	5 mg Ifetroban, Type 2 n = 5	15 mg Ifetroban, Type 1 n = 5	15 mg Ifetroban, Type 2 n = 5	50 mg Ifetroban, Type 1 n = 3	50 mg Ifetroban, Type 2 n = 5	150 mg Ifetroban, Type 2 n = 3
half-life ifetroban	36.0 (NA)	11.9 (18.4)	15.7 (16.7)	10.5 (8.6)	18.1 (14.8)	13.5 (8.2)	17.4 (11.7)
half-life ifetroban acylglucuronide	17.1 (17.5)	14.7 (19.9)	22.1 (9.5)	18.6 (10.9)	26.4 (22.0)	15.2 (9.5)	12.6 (12.4)

Population analysed: Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.

Primary outcome: Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment

Time frame: 3 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	5 mg Ifetroban, Type 1 n = 5	5 mg Ifetroban, Type 2 n = 5	15 mg Ifetroban, Type 1 n = 5	15 mg Ifetroban, Type 2 n = 5	50 mg Ifetroban, Type 1 n = 3	50 mg Ifetroban, Type 2 n = 5	150 mg Ifetroban, Type 2 n = 3
Ifetroban area under the curve (AUC) to 24 hours	964 (683)	779 (326)	2025 (639)	2463 (1497)	5151 (3579)	6634 (2166)	18612 (8408)
Ifetroban AUC to infinity	2476 (NA)	906 (481)	2959 (1941)	3259 (2866)	6505 (4032)	8204 (3461)	24657 (13425)
Ifetroban acylglucuronide AUC to 24 hours to	4371 (2050)	4145 (781)	12192 (2102)	12038 (2734)	46455 (2906)	42051 (18567)	109915 (32895)
Ifetroban acylglucuronide AUC to infinity	8440 (8730)	6128 (3721)	21962 (7404)	29857 (27688)	86457 (44928)	61673 (25672)	144951 (61311)

Primary outcome: Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment

Time frame: 3 days. Mean (Standard Deviation). Unit: ng/mL

Measure	5 mg Ifetroban, Type 1 n = 5	5 mg Ifetroban, Type 2 n = 5	15 mg Ifetroban, Type 1 n = 5	15 mg Ifetroban, Type 2 n = 5	50 mg Ifetroban, Type 1 n = 3	50 mg Ifetroban, Type 2 n = 5	150 mg Ifetroban, Type 2 n = 3
Minimum Concentration Ifetroban	1.8 (4.1)	3.4 (4.0)	14.1 (22.6)	23.5 (33.7)	43.3 (36.2)	51.1 (44.5)	150.0 (115.5)
Maximum Concentration Ifetroban	483 (445)	251 (107)	581 (114)	785 (225)	1666 (1478)	2599 (838)	6790 (2777)
Minimum Concentration Ifetroban Acylglucuronide	78.4 (56.7)	41.4 (33.1)	241.9 (89.0)	200.2 (114.3)	778.0 (583.2)	632.9 (302.9)	1755.0 (792.4)
Maximum Concentration Ifetroban Acylglucuronide	384 (103)	448 (101)	912 (194)	1214 (255)	4737 (543)	4666 (1748)	10447 (2113)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 through Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ifetroban	21 of 42 (50%)	25 of 42 (59.5%)	7 of 42
Placebo	8 of 13 (61.5%)	5 of 13 (38.5%)	2 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hepatorenal Syndrome

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brendan McGuire, MD principal investigator

University of Alabama at Birmingham

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ifetroban Injection in people with Hepatorenal Syndrome, run by Cumberland Pharmaceuticals at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01436500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.