Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/7/2019 |
| Start Date: | November 2013 |
| End Date: | December 2019 |
Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three 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.
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.
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.
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.
Inclusion Criteria:
- Prior participation in Beraprost-MR study at Harbor-UCLA
Exclusion Criteria:
- No prior participation in Beraprost study at Harbor-UCLA
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