Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01028651
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2009-12-08
Brief Title:
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a multicenter prospective observational open-label study Patients meeting inclusionexclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to standard of care This observational study collected clinical data and biologic specimens from patients who were treated for portopulmonary hypertension PoPH with a goal of achieving hemodynamic parameters appropriate for orthotopic liver transplantation candidacy including mean pulmonary arterial pressure mPAP less than 35 mmHg and pulmonary vascular resistance PVR less than 3 Wood-units WU at Week 24 in patients with severe PoPH
Detailed Description:
Treprostinil is approved as a continuous subcutaneous SC or intravenous IV infusion by the FDA for the treatment of WHO group I PAH with New York Heart Association NYHA Functional Class II III or IV symptomatology To date treprostinil has not been studied in the setting of PoPH however it is commonly prescribed in this setting This was an observational open-label multicenter study which documented the safety and efficacy profile of this agent in PoPH to facilitate orthotopic liver transplantation OLT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None