Status:
COMPLETED
Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Portopulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with portopulmonary hypertensio...
Eligibility Criteria
Inclusion
- Subjects need to fulfill all of the following 4 criteria:
- Evidence of portal hypertension (by hemodynamic measurement, or by Doppler flow of portal circulation, or by clinical evidence of portal hypertension such as esophageal or gastric varices, as evidenced by prior upper endoscopy).
- Evidence of pulmonary arterial hypertension by right heart catheterization (all three criteria need to be present) Right heart catheterization may have been performed up to 30 days prior to screening
- Mean PAP (pulmonary artery pressure) \>25 mm Hg, and
- PVR (pulmonary vascular resistance) \>240 dynes/s/cm5, and
- TPG (transpulmonary gradient = meanPAP -PAWP) \>12 mm Hg
- Baseline AST, ALT \< 5 times the upper limit of normal, total Bili \< 3.0 mg/dl, and mild liver impairment with Child -Pugh class A or B
- Ages 18 years and above
Exclusion
- Presence of any other etiology of pulmonary arterial hypertension (HIV, connective tissue disease, sickle cell, left heart failure, chronic thromboembolic PH, etc)
- Treatment with prostacyclins, other ERAs, or PDE5 inhibitors within 30 days of enrollment.
- Moribund state or anticipated death within 1 month.
- AST or ALT ≥ 5 times upper limit of normal
- Total bilirubin ≥ 3.0 mg/dl
- Significant lung disease (obstructive lung disease with FEV1 \< 1L, or FEV1/FVC \<50%; or restrictive lung disease with Total Lung Capacity \< 60% predicted). PFTs may have been performed up to 6 months prior to enrollment.
- Pregnancy
- Age \<18 years
- Child -Pugh class C
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01224210
Start Date
March 1 2010
End Date
March 1 2020
Last Update
January 12 2021
Active Locations (6)
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1
UCSD Medical Center
La Jolla, California, United States, 92093
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599