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

• Status: Withdrawn
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ochsner Health System
• Collaborator: Gilead Sciences
• Treatments: Ambrisentan; Tadalafil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.