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

NCT ID: NCT03309592

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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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 (mPAP) \>35 mmHg and 100% when the mPAP is greater than 50 mmHg; therefore, making moderate to severe POPH a contraindication to liver transplants. Those recipients with significant pulmonary artery pressure (PAP) may be denied the opportunity for transplant unless the mPAP is brought below 35 mmHg with medical treatment. This study will test the efficacy \& safety of the combination of using ambrisentan and tadalfil in reducing the Pulmonary Arterial Pressure to below 35 mmHg in patients with moderate to severe POPH as a means to candidacy for liver transplantation.

Conditions

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Portopulmonary Hypertension Pulmonary Hypertension Cirrhosis, Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination Therapy

Qualifying participants will begin combination therapy with ambrisentan pill 5 mg daily and tadalafil pill 20 mg. After one week of therapy, patients will increase tadalafil pill to 40 mg daily and continue ambrisentan pill 5 mg daily. On day 15, patients will increase ambrisentan pill to 10 mg daily and continue at 40 mg of tadalafil pill daily.

Group Type OTHER

Ambrisentan Pill

Intervention Type DRUG

Will be administered as stated in Arm/Group Descriptions

Tadalafil Pill

Intervention Type DRUG

Will be administered as stated in Arm/Group Descriptions

Interventions

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Ambrisentan Pill

Will be administered as stated in Arm/Group Descriptions

Intervention Type DRUG

Tadalafil Pill

Will be administered as stated in Arm/Group Descriptions

Intervention Type DRUG

Other Intervention Names

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Letairis Adcirca

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacy Mandras, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Pulmonary Hypertension

Locations

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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ESCALATE-PPH

Identifier Type: -

Identifier Source: org_study_id