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NCT01028651 · ClinicalTrials.gov registry record
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
A clinical trial, sponsored by United Therapeutics.
- Completed
- Registry status
- 13
- Enrollment target
NCT01028651: Completed study, sponsored by United Therapeutics.
NCT01028651 is a clinical trial that has completed, run by United Therapeutics. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01028651 has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
Study Summary
This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion 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.
Primary Outcome
The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).
Interventions
- DRUG Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-04 |
What the finished NCT01028651 record still lists
NCT01028651 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Treprostinil is the first listed.
NCT01028651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01028651 about?
NCT01028651 is a clinical study titled "A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension". This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion 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 b...
What is the current status of trial NCT01028651?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2011-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01028651?
The interventions under investigation include: Treprostinil (DRUG).
Who is sponsoring clinical trial NCT01028651?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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