Trial · NCT01436500

Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients

NCT01436500, Phase 2, Completed, Cumberland Pharmaceuticals; results first posted 2017-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients. Trials, record NCT01436500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01436500

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
NCT number: NCT01436500
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Hepatorenal Syndrome
Interventions: Ifetroban Injection, Placebo
First posted: 2011-09-19
Last updated: 2017-03-01
Results first posted: 2017-02-14

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	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.
Primary	Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment	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.
Primary	Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment	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.
Secondary	Safety: Day 28 Mortality	28 days
Secondary	Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL	Day 0 through Day 5
Secondary	The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements	Day 0 to Day 5
Secondary	Change in 24-hour Urine Volume	Baseline to Hour 96	The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	3 days	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.	hours	MEAN
PRIMARY	Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment	3 days	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.	ng*hr/mL	MEAN
PRIMARY	Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment	3 days	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.	ng/mL	MEAN
SECONDARY	Safety: Day 28 Mortality	28 days		percentage of participants	NUMBER
SECONDARY	Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL	Day 0 through Day 5		percentage of participants	NUMBER
SECONDARY	The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements	Day 0 to Day 5		percentage of participants	NUMBER
SECONDARY	Change in 24-hour Urine Volume	Baseline to Hour 96	Data were missing for the post-treatment urine volume measurements in 9 of 42 ifetroban patients and 3 of 13 placebo patients so they were excluded from the analysis.	mL	MEAN

Source ClinicalTrials.gov

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	5 mg Ifetroban, Type 1	half-life ifetroban	36.0	Standard Deviation NA	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	5 mg Ifetroban, Type 2	half-life ifetroban	11.9	Standard Deviation 18.4	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	15 mg Ifetroban, Type 1	half-life ifetroban	15.7	Standard Deviation 16.7	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	15 mg Ifetroban, Type 2	half-life ifetroban	10.5	Standard Deviation 8.6	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	50 mg Ifetroban, Type 1	half-life ifetroban	18.1	Standard Deviation 14.8	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	50 mg Ifetroban, Type 2	half-life ifetroban	13.5	Standard Deviation 8.2	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	150 mg Ifetroban, Type 2	half-life ifetroban	17.4	Standard Deviation 11.7	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	5 mg Ifetroban, Type 1	half-life ifetroban acylglucuronide	17.1	Standard Deviation 17.5	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	5 mg Ifetroban, Type 2	half-life ifetroban acylglucuronide	14.7	Standard Deviation 19.9	hours
Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide	15 mg Ifetroban, Type 1	half-life ifetroban acylglucuronide	22.1	Standard Deviation 9.5	hours

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	5 mg Ifetroban	12
Overall Study	STARTED	15 mg Ifetroban	12
Overall Study	STARTED	50 mg Ifetroban	12
Overall Study	STARTED	150 mg Ifetroban	6
Overall Study	STARTED	Placebo	13
Overall Study	COMPLETED	5 mg Ifetroban	9
Overall Study	COMPLETED	15 mg Ifetroban	9
Overall Study	COMPLETED	50 mg Ifetroban	7
Overall Study	COMPLETED	150 mg Ifetroban	5
Overall Study	COMPLETED	Placebo	9

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	abdominal pain	Gastrointestinal disorders	Ifetroban	4	42
other	abdominal pain	Gastrointestinal disorders	Placebo	0	13
other	Dyspnoea	Cardiac disorders	Ifetroban	5	42
other	Dyspnoea	Cardiac disorders	Placebo	0	13
other	atrial fibrillation	Cardiac disorders	Ifetroban	3	42
other	atrial fibrillation	Cardiac disorders	Placebo	0	13
other	chronic hepatic failure	Hepatobiliary disorders	Ifetroban	3	42
other	chronic hepatic failure	Hepatobiliary disorders	Placebo	0	13
other	nausea	Gastrointestinal disorders	Ifetroban	3	42
other	nausea	Gastrointestinal disorders	Placebo	0	13

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ifetroban	7	42
Total, all-cause mortality	Placebo	2	13
Total, other adverse events	Ifetroban	25	42
Total, other adverse events	Placebo	5	13
Total, serious adverse events	Ifetroban	21	42
Total, serious adverse events	Placebo	8	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ifetroban vs Placebo: deaths from any cause	Trial comparisons
Ifetroban vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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