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Main
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Note: This record shows only the 20 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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15 April 2013 |
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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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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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Phase 4 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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November 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://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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Observational Model: Cohort, Time Perspective: Prospective
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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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Michael Krowka, 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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Mayo Clinic |
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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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James Runo, 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 Wisconsin, Madison |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must:
1. Confirmed severe PoPH documented on standard of care right-heart catheterization
(RHC) with a plan to initiate treprostinil therapy, as recommended by the
treating physician state within 30 days.
2. Have portal hypertension.
3. Be otherwise suitable candidates for OLT.
4. Treprostinil therapy must be recommended by the treating physician per standard
of care.
5. Be NYHA Class II, III, or IV
6. Have Pulmonary Capillary Wedge Pressure (PCW) < 18 mmHg AND transpulmonary
gradient (TPG) = 15 mmHg Severe PAH is defined as a resting mean pulmonary
artery pressure (mPA) > 25 mmHg AND pulmonary vascular resistance (PVR) = 3
wood-units by right-heart catheterization (RHC) performed as part of standard of
care evaluation within 30 days of enrollment
Exclusion Criteria:
- Patients must not:
1. Be taking any investigational therapy as part of a clinical trial for any
indication within 30 days of enrollment.
2. Be receiving any vasodilator treatment for pulmonary hypertension (i.e.
bosentan, sitaxsentan, ambrisentan, sildenafil, tadalafil, epoprostenol,
beraprost, iloprost, inhaled treprostinil) at the time of enrollment.
3. Exhibit renal failure requiring hemodialysis.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Portopulmonary Hypertension
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Pulmonary Arterial Hypertension
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Pulmonary Hypertension
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Intervention(s)
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Drug: Treprostinil sodium
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Primary Outcome(s)
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To estimate the probability of achieving a mPAP to less than 35 mmHg and a PVR less than 3 Wood-units in subjects with severe portopulmonary hypertension undergoing OLT treated for 24 weeks with treprostinil.
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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To assess the effect of treprostinil therapy on safety, secondary efficacy endpoints and chemokine profiles.
[Time Frame: 24 weeks, and 30 day post-OLT and one year post-OLT]
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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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