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

NCT01966302 | Completed Phase 2

• 1 other identifier: Compassionate use BPS-314d-MR
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; prostacyclin; oral

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing Adverse Events

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

  2 years

Study Arms (1)

Beraprost open label

EXPERIMENTAL

Compassionate use access to open label BPS-314d-MR

Drug: BPS-314d-MR

Interventions

BPS-314d-MR DRUG

15-150 mcg po BID,

Also known as: Beraprost 314-d modified release

Beraprost open label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No prior participation in Beraprost study at Harbor-UCLA

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Lung Biotechnology PBC: collaborator

Study Sites (1)

Los Angeles Biomedical research Institute

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

beraprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ronald J Oudiz, MD

  Los Angeles BRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 21, 2013
• Study Start: November 1, 2013
• Primary Completion: June 2, 2019
• Study Completion: June 2, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

US (1)