Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01966302
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2013-10-15
Brief Title:
Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
Compassionate Use of Beraprost Sodium 314d Modified Release BPS-314d-MR for Three Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if Lung LLCs 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 US 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 andor 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
Patients may also be taking Tyvaso treprostinil Tracleer bosentan Letairis ambrisentan Adcirca tadalafil andor 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
Detailed Description:
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 LLCs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None