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Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients

NCT01436500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-03-01

Study results available
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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.

Conditions

  • Hepatorenal Syndrome

Interventions

DRUG

Ifetroban Injection

Ifetroban sodium injectable, diluted in sterile water with 5% dextrose

DRUG

Placebo

Sterile water with 5% Dextrose

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Brendan McGuire, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436500 on ClinicalTrials.gov