Status:
WITHDRAWN
Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
Gilead Sciences
Conditions:
Portopulmonary Hypertension
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the combination of ambrisentan and tadalafil in reducing mPAP to below 35mmHg in patients with moderate to severe Portopulmonary Hyp...
Detailed Description
The outcome of liver transplantation (LT) in the presence of moderate to severe POPH is significantly poor with a 50% reported mortality rate in LT recipients having a mean pulmonary artery pressure (...
Eligibility Criteria
Inclusion
- Child-Pugh Class Class A \& B Cirrhosis
- mPAP ≥35mmHg
- Pulmonary Capillary Wedge Pressure (PWCP) \<15mmHg on Right Heart Catheterization's (RHCs)
- mPAP \> 50mmHg will be considered eligible unless they are World Health Organization (WHO) Functional Class IV
Exclusion
- End stage renal disease on hemodialysis (ESRD on HD)
- Renal dysfunction and GFR \< 30
- AST, ALT \> 5 times the upper limit of normal
- Total bilirubin ≥ 6.0
- INR \> 2
- Initially, Child-Pugh Class C patients will be excluded; however, after the first 5 patients are included, if there is no signal of worsening liver function, the protocol may be amended to include patients with Class C cirrhosis.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03309592
Start Date
October 12 2017
End Date
November 1 2018
Last Update
December 7 2018
Active Locations (1)
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1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121