Clinical Trial Finder

BPS-314d-MR-PAH-303 (BEAT OLE)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03657095
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Lung Biotechnology PBC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Israel, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Arterial Hypertension
Additional 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.

Arms & Interventions

Arms

Experimental: Beraprost Sodium 314d Modified Release tablets

15 μg esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) for oral administration as 1 or 2 tablets four times a day (QID).

Interventions

Drug: - Beraprost Sodium 314d Modified Release tablets

15 μg esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) for oral administration as 1 or 2 tablets four times a day (QID)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Georgia Clinical Research, Austell, Georgia

Status

Address

Georgia Clinical Research

Austell, Georgia, 30106

The University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

The University of Alabama at Birmingham

Birmingham, Alabama, 35294

Cedars-Sinai Medical Center, Beverly Hills, California

Status

Address

Cedars-Sinai Medical Center

Beverly Hills, California, 90211

La Jolla, California

Status

Address

University of California San Diego Medical Center

La Jolla, California, 92093

Los Angeles, California

Status

Address

University of California Los Angeles UCLA

Los Angeles, California, 90024

West Los Angeles VA Healthcare Center, Los Angeles, California

Status

Address

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073

Santa Barbara Pulmonary Associates, Santa Barbara, California

Status

Address

Santa Barbara Pulmonary Associates

Santa Barbara, California, 93102

Stanford Hospital and Clinics, Stanford, California

Status

Address

Stanford Hospital and Clinics

Stanford, California, 94305

Harbor-UCLA Medical Center, Torrance, California

Status

Address

Harbor-UCLA Medical Center

Torrance, California, 90502

Allianz Research Institute, Westminster, California

Status

Address

Allianz Research Institute

Westminster, California, 92683

Aurora, Colorado

Status

Address

University of Colorado Health Sciences Center

Aurora, Colorado, 80045

Aurora Denver Cardiology Associates, Denver, Colorado

Status

Address

Aurora Denver Cardiology Associates

Denver, Colorado, 80128

South Denver Cardiology Associates, Littleton, Colorado

Status

Address

South Denver Cardiology Associates

Littleton, Colorado, 80120

Bay Area Cardiology Research, Brandon, Florida

Status

Address

Bay Area Cardiology Research

Brandon, Florida, 33511

Gainesville, Florida

Status

Address

University of Florida Clinical Research Center

Gainesville, Florida, 32610

Florida Hospital, Orlando, Florida

Status

Address

Florida Hospital

Orlando, Florida, 32803

South Miami Heart Specialists, South Miami, Florida

Status

Address

South Miami Heart Specialists

South Miami, Florida, 33143

Cleveland Clinic Florida, Weston, Florida

Status

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Emory University, Atlanta, Georgia

Status

Address

Emory University

Atlanta, Georgia, 30322

Pulmonary & Critical Care of Atlanta, Atlanta, Georgia

Status

Address

Pulmonary & Critical Care of Atlanta

Atlanta, Georgia, 30342

Indiana University Health North Hospital, Indianapolis, Indiana

Status

Address

Indiana University Health North Hospital

Indianapolis, Indiana, 46202

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 54224

Louisville, Kentucky

Status

Address

University of Louisville Research Foundation

Louisville, Kentucky, 40202

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

University of Maryland Medical Center, Baltimore, Maryland

Status

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21205

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Beaumont Health, Troy, Michigan

Status

Address

Beaumont Health

Troy, Michigan, 48085

Albany Medical Center, Albany, New York

Status

Address

Albany Medical Center

Albany, New York, 12208

The Mount Sinai Hospital, New York, New York

Status

Address

The Mount Sinai Hospital

New York, New York, 10029

Chapel Hill, North Carolina

Status

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Columbus, Ohio

Status

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221

The University of Toledo, Toledo, Ohio

Status

Address

The University of Toledo

Toledo, Ohio, 43614

Oregon Health and Science University, Portland, Oregon

Status

Address

Oregon Health and Science University

Portland, Oregon, 97239

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Rhode Island Hospital, Providence, Rhode Island

Status

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Anderson Pharmaceutical Research, LLC, Anderson, South Carolina

Status

Address

Anderson Pharmaceutical Research, LLC

Anderson, South Carolina, 29621

UT Southwestern Medical Center, Dallas, Texas

Status

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Scott & White Memorial Hospital, Temple, Texas

Status

Address

Scott & White Memorial Hospital

Temple, Texas, 76508

Norfolk, Virginia

Status

Address

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

Rabin Medical Center, Petah Tikva, Israel

Status

Address

Rabin Medical Center

Petah Tikva, , 49100

The Chaim Sheba Medical Center, Tel Hashomer, Israel

Status

Address

The Chaim Sheba Medical Center

Tel Hashomer, , 52621

Powered By

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

Submit Feedback

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation in a clinical trial or study.