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Completed

NCT Number: NCT01966302

Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to see if Lung LLC's new experimental formulation of the medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration for use in the general public. This research study is for patients who have pulmonary arterial hypertension (PAH) and have just completed taking part in an earlier research study and received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve their PAH.

Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH. The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The increased blood pressure in the lungs places a strain on the heart. The strain causes the heart to pump less blood into the lungs, causing shortness of breath and tiredness. The strain on the heart weakens the heart muscle making it less able to pump blood, a condition called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles Biomedical research Institute

Torrance, California, 90502, United States

About this study

According to Lung LLC, and from my review of summary results contained within the most recent version of the BPS-314d-MR Investigators' Brochure I concur, BPS-314d- MR has been shown to have a similar safety and pharmacokinetic profile in healthy volunteers to BPS-MR. It is also my understanding that at an End of Phase II meeting in April of this year, FDA acknowledged Lung LLC's intention to continue the development of BPS-314d-MR by conducting a Phase III pivotal study in PAH patients. This study, BPS-314d-MR-PAH-302 was subsequently initiated this past June.

In my opinion, and based upon the similarities of the two formulations, it is in the best interest of our patients to transition their treatment to BPS-314d-MR.

Lung LLC has agreed to supply BPS-314d-MR for the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior participation in Beraprost-MR study at Harbor-UCLA

Exclusion criteria

  • No prior participation in Beraprost study at Harbor-UCLA

Treatment and study plan

BPS-314d-MR

Drug

15-150 mcg po BID,

Other names: Beraprost 314-d modified release

Primary outcomes

  1. Number of participants experiencing Adverse Events

    Time frame: 2 years

    To determine the overall safety of open label study drug by tabulating the number of patients experiencing Adverse Events

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Collaborators

  • Lung Biotechnology PBC

Registry information

Official study title

Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2013
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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