Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension

Withdrawn before enrolling · Phase 4

Conditions studied: Portopulmonary Hypertension, Pulmonary Hypertension, Cirrhosis, Liver

In brief

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 Hypertension (POPH) as a means to candidacy for liver transplantation.

Key facts

Study ID

NCT03309592

Run by

Ochsner Health System

People needed

0

Starts

2017-10-12

Expected to finish

2018-11-01

Last updated by the study team

2018-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ochsner Clinic Foundation — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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