Summary

for people ages 18-85 (full criteria)
at UCSD UCLA
study started
estimated completion:

Description

Summary

This is a multi-center, open-label study for eligible subjects who were actively participating in the BPS-314d-MR-PAH-302 study at the time the study was concluded. This OLE study will evaluate the safety, tolerability and efficacy of long-term treatment of the esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) study drug.

Official Title

An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients

Details

Subjects will sign an informed consent to continue treatment for PAH with esuberaprost sodium tablets in this open-label extension (OLE) study. At the Enrollment Visit for this study, subjects will begin a blinded transition from the BPS-314d-MR-PAH-302 study to the OLE study over a 4-week period. The first dose for all subjects in this OLE study will be 2 tablets. During this blinded transition period, those subjects on active study drug in the BPS-314d-MR-PAH-302 study will continue with blinded active study drug 4-times daily (QID); those subjects on placebo study drug will receive one active tablet and one placebo tablet QID (blinded) during the first 2 weeks and increase to 2 active tablets QID (blinded) thereafter. After the first dose, the investigator may adjust the dose as medically warranted. The maximum dose for this study is 30 μg QID with a minimum accepted dose as 15 μg QID. For the first 4 weeks, contact with the subject should occur weekly to ensure up-titration to the fixed dose is tolerated and assess adverse events (AEs).

Subjects will return to the clinic at Week 4 to be supplied open-label esuberaprost sodium tablets and complete protocol specified procedures. At the Week 4 Visit, subjects will be dosed with two 15 μg tablets (30 μg total), administered orally QID (provided the target dose is tolerated) or follow the Investigator's (or designee's) directions if adjustment is needed. Following the Week 4 Visit, each subject will return to the clinic at Months 3, 6, 9, and 12, and quarterly thereafter for assessments.

At the conclusion of the study or if a subject discontinues the study prematurely, subjects will return to the clinic for an End-of-Study (EOS) Visit. Subjects will be provided instructions about down titration off esuberaprost sodium tablets by the investigator.

Keywords

Pulmonary Arterial Hypertension Hypertension Familial Primary Pulmonary Hypertension Hypertension, Pulmonary Lung Diseases Vascular Diseases Cardiovascular Diseases Respiratory Tract Diseases Prostacyclin Beraprost Epoprostenol Platelet Aggregation Inhibitors Vasodilator Agents Antihypertensive Agents Beraprost Sodium 314d Modified Release tablets

Eligibility

You can join if…

Open to people ages 18-85

  1. Subject must have been actively participating in Study BPS-314d-MR-PAH-302 when the sponsor concluded that study.
  2. In the Investigator's opinion, subject must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)approved informed consent form (ICF) and must sign the form prior to the initiation of any study procedures.
  3. Women of child-bearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using two highly-effective methods of contraception (defined as a method of birth control that results in a low failure rate, i.e., less than 1% per year, such as approved hormonal contraceptives,barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device). Subject must have a negative pregnancy test at the BPS-314d-MR-PAH-302 EOS Visit / BPS-314d-MR-PAH-303 Enrollment Visit.
  4. Subject must be willing and able to comply with study requirements and restrictions.

You CAN'T join if...

  1. Subject is pregnant or lactating.
  2. Subject is scheduled to receive another investigational drug, device, or therapy during the course of the study.
  3. Subject is taking or intends to take any prostacyclin / prostacyclin analog or IP receptor agonist (EXCEPT FOR treprostinil, inhaled [Tyvaso®]).
  4. Subject has any other clinically significant illness or other reason that, in the opinion of the investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

Locations

  • University of California San Diego Medical Center
    La Jolla California 92093 United States
  • University of California Los Angeles UCLA
    Los Angeles California 90024 United States
  • Harbor-UCLA Medical Center
    Torrance California 90502 United States
  • West Los Angeles VA Healthcare Center
    Los Angeles California 90073 United States
  • Cedars-Sinai Medical Center
    Beverly Hills California 90211 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Lung Biotechnology PBC
ID
NCT03657095
Phase
Phase 3
Study Type
Interventional
Last Updated