Study Stopped
The pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.
A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
BEAT OLE
An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients
1 other identifier
interventional
112
2 countries
45
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedStudy Start
First participant enrolled
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2019
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedSeptember 7, 2020
September 1, 2020
7 months
May 18, 2018
August 4, 2020
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) is an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), or persistent or significant disability/incapacity. AEs included both SAEs and non-serious AEs. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline up to Month 7
Secondary Outcomes (4)
Area Walked for the 6 Minute Walk Distance (6MWD) Test
Week 4 and then every 3 months until study termination (Month 7)
Borg Dyspnea Score
Week 4 and then every 3 months until study termination (Month 7)
Number of Participants in Each Category of the World Health Organization (WHO) Functional Class (FC)
Week 4 and then every 3 months until study termination (Month 7)
Number of Participants With a TEAE of N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP) Increased
Baseline up to Month 7
Study Arms (2)
Esuberaprost
EXPERIMENTALParticipants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study will receive 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which will include the 4 weeks of blinded transition).
Placebo/Esuberaprost
PLACEBO COMPARATORParticipants who received placebo during the BPS-314d-MR-PAH-302 double-blind study will receive 1 esuberaprost tablet and 1 placebo tablet QID during the first 2 weeks of the blinded transition and then receive 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which will include the other 2 weeks of the total 4-week blinded transition).
Interventions
Sodium tablets
Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Cedars-Sinai Medical Center
Beverly Hills, California, 90211, United States
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
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073, United States
Santa Barbara Pulmonary Associates
Santa Barbara, California, 93102, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Allianz Research Institute
Westminster, California, 92683, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Aurora Denver Cardiology Associates
Denver, Colorado, 80128, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Bay Area Cardiology Research
Brandon, Florida, 33511, United States
University of Florida Clinical Research Center
Gainesville, Florida, 32610, United States
Florida Hospital
Orlando, Florida, 32803, United States
South Miami Heart Specialists
South Miami, Florida, 33143, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30322, United States
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, 30342, United States
Georgia Clinical Research
Austell, Georgia, 30106, United States
Indiana University Health North Hospital
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 54224, United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beaumont Health
Troy, Michigan, 48085, United States
Albany Medical Center
Albany, New York, 12208, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221, United States
The University of Toledo
Toledo, Ohio, 43614, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Anderson Pharmaceutical Research, LLC
Anderson, South Carolina, 29621, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
MeSH Terms
Conditions
Interventions
Limitations and Caveats
The study was terminated early due to the pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.
Results Point of Contact
- Title
- Lung Biotechnology PBC
- Organization
- Lung Biotechnology PBC Study Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Treatment during the first 4 weeks of this study will be double-blind. The Investigator and study staff, the participants, the monitors, and the Sponsor will remain blinded to the treatment group allocation from BPS-314d-MR-PAH-302 double-blind study (NCT01908699) and to study drug during the first 4 weeks of the OLE study while the participants transition to the OLE treatment. After the 4 weeks, the study will continue as unblinded and open label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2018
First Posted
September 4, 2018
Study Start
December 10, 2018
Primary Completion
July 20, 2019
Study Completion
July 20, 2019
Last Updated
September 7, 2020
Results First Posted
September 7, 2020
Record last verified: 2020-09