NCT03309592

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

June 5, 2017

Last Update Submit

December 5, 2018

Conditions

Portopulmonary HypertensionPulmonary HypertensionCirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Reduction in mPAP to 35mmHg

    A Right Heart Catheterization will be performed in order to see if there's a reduction in mPAP to less than 35mmHg from baseline

    2 months post initiation of therapy

Secondary Outcomes (14)

  • Blood Pressure

    2 months post therapy

  • mPAP Reduction

    2 months post initiation of therapy

  • Post-Transplant Survival Outcome: Alive or Dead at 30 days

    Post-op Day 1 and 30

  • Kidney function evaluation through measurement of Creatinine levels (mg/dL)

    baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant

  • Liver Function test measured by AST (iu/L)

    baseline, 1 month, 2 month, 3 month, 6 month, 9 month, 12 months/end of treatment, 1 month post transplant

  • +9 more secondary outcomes

Study Arms (1)

Combination Therapy

OTHER

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.

Drug: Ambrisentan PillDrug: Tadalafil Pill

Interventions

Ambrisentan PillDRUG

Will be administered as stated in Arm/Group Descriptions

Also known as: Letairis
Combination Therapy
Tadalafil PillDRUG

Will be administered as stated in Arm/Group Descriptions

Also known as: Adcirca
Combination Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryLiver Cirrhosis

Interventions

ambrisentanTadalafil

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Stacy Mandras, MD

    Director, Pulmonary Hypertension

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2017

First Posted

October 13, 2017

Study Start

October 12, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)