CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Ifetroban Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01436500
NCT01436500Phase 2Completed
CompareCT.gov

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

Cumberland Pharmaceuticals·interventional·Posted Sep 19, 2011·Updated Mar 1, 2017

In Brief

A Phase 2 clinical trial evaluating Ifetroban Injection and Placebo for Hepatorenal Syndrome. Completed, enrolled 55 participants across 12 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatorenal Syndrome
CountriesIndia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.8 years ago

Interventions

Ifetroban Injectiondrug

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

Placebodrug

Sterile water with 5% Dextrose