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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01028651 |
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Date of registration:
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08/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
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Scientific title:
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An Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01028651 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Aaron Waxman, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Name:
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Sonja Bartolome, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Name:
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Rajan Saggar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Name:
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Micah Fisher, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must:
1. Had portal hypertension.
2. Be otherwise suitable candidates for OLT.
3. Had severe pulmonary arterial hypertension (PAH) defined as a resting mean
pulmonary arterial pressure (mPAP) >35 mmHg and pulmonary vascular resistance
(PVR) =3 Wood Units (WU) by right heart catheterization (RHC) performed as part
of standard of care evaluation within 90 days of enrollment.
4. Treprostinil therapy must be recommended by the treating physician per standard
of care.
5. Be NYHA Functional Class II, III, or IV.
6. Had pulmonary capillary wedge (PCW) pressure =18 mmHg and transpulmonary gradient
(TPG) =15 mmHg.
Exclusion Criteria:
- Patients must not:
1. Had received any any investigational therapy as part of a clinical trial for any
indication within 30 days prior to enrollment.
2. Had a change in dose of treatment for PAH (bosentan [Tracleer], ambrisentan
[Letairis], tadalafil [Adcirca], or sildenafil [Revatio]), within 30 days prior
to enrollment. That is, subjects may have been treated with any of these agents
provided the dose was stable for at least 30 days prior to enrollment.
3. Had renal failure requiring hemodialysis.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Portopulmonary Hypertension
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Pulmonary Hypertension
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Intervention(s)
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Drug: Treprostinil
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Primary Outcome(s)
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Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.
[Time Frame: 24 Weeks]
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Secondary Outcome(s)
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Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24
[Time Frame: Baseline and Weeks 12 and 24]
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Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
[Time Frame: 24 weeks]
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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]
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Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24
[Time Frame: 24 weeks]
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Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.
[Time Frame: Baseline and Weeks 12 and 24]
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Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24
[Time Frame: 24 weeks]
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Change in Quality of Life From Baseline to Weeks 12 and 24
[Time Frame: Baseline and Weeks 12 and 24]
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Change in Cardiac Output at Rest From Baseline to Week 24
[Time Frame: 24 weeks]
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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]
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Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24
[Time Frame: Baseline and Weeks 12 and 24]
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Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24
[Time Frame: Baseline and Weeks 12 and 24]
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Change in Heart Rate at Rest From Baseline to Week 24
[Time Frame: 24 weeks]
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Secondary ID(s)
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RIV-PH-414
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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