Trials / Completed
CompletedNCT01436500
Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
A Multi-Center, Double-Blind, Randomized, Controlled Study to Determine the Safety and Pharmacokinetics of Ifetroban Injection in Hepatorenal Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ifetroban Injection | Ifetroban sodium injectable, diluted in sterile water with 5% dextrose |
| DRUG | Placebo | Sterile water with 5% Dextrose |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2015-06-01
- Completion
- 2015-07-01
- First posted
- 2011-09-19
- Last updated
- 2017-03-01
- Results posted
- 2017-02-14
Locations
12 sites across 2 countries: United States, India
Source: ClinicalTrials.gov record NCT01436500. Inclusion in this directory is not an endorsement.