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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lung Rx
Information provided by (Responsible Party):
ronald oudiz, m.d., Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01966302
First received: October 15, 2013
Last updated: November 28, 2013
Last verified: November 2013

October 15, 2013
November 28, 2013
November 2013
December 2015   (final data collection date for primary outcome measure)
Number of participants experiencing Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To determine the overall safety of open label study drug by tabulating the number of patients experiencing Adverse Events
Same as current
Complete list of historical versions of study NCT01966302 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: BPS-314d-MR
15-150 mcg po BID,
Other Name: Beraprost 314-d modified release
Experimental: Beraprost open label
Compassionate use access to open label BPS-314d-MR
Intervention: Drug: BPS-314d-MR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No prior participation in Beraprost study at Harbor-UCLA
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01966302
Compassionate use BPS-314d-MR
No
ronald oudiz, m.d., Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
Lung Rx
Principal Investigator: Ronald J Oudiz, MD Los Angeles BRI
Los Angeles Biomedical Research Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP