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A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Brigham and Women's Hospital
University of Texas
Emory University
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01028651
First received: December 8, 2009
Last updated: January 5, 2017
Last verified: January 2017
Results First Received: September 14, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Portopulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Intervention: Drug: Treprostinil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treprostinil Injection Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).

Participant Flow:   Overall Study
    Treprostinil Injection
STARTED   13 
COMPLETED   10 
NOT COMPLETED   3 
Death                2 
Adverse Event                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Treprostinil Injection Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).

Baseline Measures
   Treprostinil Injection 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.8  (8.00) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  61.5% 
Male      5  38.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      5  38.5% 
Not Hispanic or Latino      8  61.5% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      13 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   13 


  Outcome Measures
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1.  Primary:   Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.   [ Time Frame: 24 Weeks ]

2.  Secondary:   Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24   [ Time Frame: 24 weeks ]

3.  Secondary:   Change in Heart Rate at Rest From Baseline to Week 24   [ Time Frame: 24 weeks ]

4.  Secondary:   Change in Cardiac Output at Rest From Baseline to Week 24   [ Time Frame: 24 weeks ]

5.  Secondary:   Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24   [ Time Frame: 24 weeks ]

6.  Secondary:   Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24   [ Time Frame: 24 weeks ]

7.  Secondary:   Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.   [ Time Frame: Baseline and Weeks 12 and 24 ]

8.  Secondary:   Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

9.  Secondary:   Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

10.  Secondary:   Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

11.  Secondary:   Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

12.  Secondary:   Change in Quality of Life From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

13.  Secondary:   Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24   [ Time Frame: Baseline to Weeks 12 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kevin Laliberte, PharmD
Organization: United Therapeutics Corp.
phone: 919-425-8176
e-mail: KLaliberte@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01028651     History of Changes
Other Study ID Numbers: RIV-PH-414
Study First Received: December 8, 2009
Results First Received: September 14, 2016
Last Updated: January 5, 2017