A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term treatment with esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets).

Key facts

Study ID

NCT03657095

Run by

Lung Biotechnology PBC

People needed

112

Starts

2018-12-10

Expected to finish

2019-07-20

Last updated by the study team

2020-09-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must have been actively participating in the double-blind study, BPS-314d-MR-PAH-302 (NCT01908699), when the Sponsor concluded that study.
• In the Investigator's opinion, participant 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.
• Women of child-bearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must be practicing abstinence or using 2 highly-effective methods of contraception (defined as a method of birth control that results in a low failure rate [that is, 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]). Participant must have a negative pregnancy test at the BPS-314d-MR-PAH-302 EOS Visit / BPS-314d-MR-PAH-303 Enrollment Visit.
• Participant must be willing and able to comply with study requirements and restrictions.

You may not qualify if…

• Participant is pregnant or lactating.
• Participant is scheduled to receive another investigational drug, device, or therapy during the course of the study.
• Participant is taking or intends to take any prostacyclin / prostacyclin (IP) analog or IP receptor agonist (except for treprostinil, inhaled [Tyvaso®]).
• Participant has any other clinically significant illness or other reason that, in the opinion of the Investigator, might put the participant at risk of harm during the study or might adversely affect the interpretation of the study data.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• University of California Los Angeles UCLA — Los Angeles, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• Santa Barbara Pulmonary Associates — Santa Barbara, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Allianz Research Institute — Westminster, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Aurora Denver Cardiology Associates — Denver, Colorado, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Bay Area Cardiology Research — Brandon, Florida, United States
• University of Florida Clinical Research Center — Gainesville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• South Miami Heart Specialists — South Miami, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Pulmonary & Critical Care of Atlanta — Atlanta, Georgia, United States
• Georgia Clinical Research — Austell, Georgia, United States
• Indiana University Health North Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville Research Foundation — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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