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 Biotechnology Inc.
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
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: BPS-314d-MR
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 3
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beraprost open label
Compassionate use access to open label BPS-314d-MR
Drug: BPS-314d-MR
15-150 mcg po BID,
Other Name: Beraprost 314-d modified release

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No prior participation in Beraprost study at Harbor-UCLA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966302

Locations
United States, California
Los Angeles Biomedical research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Lung Biotechnology Inc.
Investigators
Principal Investigator: Ronald J Oudiz, MD Los Angeles BRI
  More Information

No publications provided

Responsible Party: ronald oudiz, m.d., Professor of Medicine, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01966302     History of Changes
Other Study ID Numbers: Compassionate use BPS-314d-MR
Study First Received: October 15, 2013
Last Updated: November 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Los Angeles Biomedical Research Institute:
Pulmonary Arterial Hypertension
prostacyclin
oral

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Beraprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 15, 2014