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

NCT ID: NCT03657095

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2019-07-20

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).

Detailed Description

Participants will sign an informed consent to continue treatment for pulmonary arterial hypertension (PAH) with esuberaprost sodium tablets in this OLE study. At the Enrollment Visit for this OLE study, participants will begin a blinded transition from the BPS-314d-MR-PAH-302 double-blind study to this study over 4 weeks. The first dose for all participants in this OLE study will be 2 tablets. During this blinded transition, those participants on active study drug in the BPS-314d-MR-PAH-302 study will continue with blinded active study drug 4-times daily (QID); those participants who were on placebo study drug will receive 1 active tablet and 1 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 microgram (μg) QID with a minimum accepted dose as 15 μg QID. For the first 4 weeks, contact with the participant should occur weekly to ensure up-titration to the fixed dose is tolerated and assess adverse events (AEs).

Participants 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, participants 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 participant will return to the clinic at Months 3, 6, 9, and 12, and quarterly thereafter for assessments.

This study is expected to continue until the first of any of the following are reached: the study drug is commercially available, the Sponsor discontinues the study, or the Sponsor offers enrollment in another study (estimated to be up to 2 years). At the conclusion of the study or if a participant discontinues the study prematurely, participants will return to the clinic for an End-of-Study (EOS) Visit. Participants will be provided instructions about down titration off esuberaprost sodium tablets by the Investigator.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esuberaprost

Participants 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).

Group Type: EXPERIMENTAL

Esuberaprost

Intervention Type: DRUG

Sodium tablets

Placebo/Esuberaprost

Participants 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).

Group Type: PLACEBO_COMPARATOR

Esuberaprost

Intervention Type: DRUG

Sodium tablets

Placebo

Intervention Type: DRUG

Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.

Interventions

Esuberaprost

Sodium tablets

Intervention Type: DRUG

Placebo

Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.

Intervention Type: DRUG

Other Intervention Names

Beraprost Sodium 314d Modified Release tablets

Eligibility Criteria

Inclusion Criteria

1. Participant must have been actively participating in the double-blind study, BPS-314d-MR-PAH-302 (NCT01908699), when the Sponsor concluded that study.

2. 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.

3. 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.

4. Participant must be willing and able to comply with study requirements and restrictions.

Exclusion Criteria

1. Participant is pregnant or lactating.

2. Participant is scheduled to receive another investigational drug, device, or therapy during the course of the study.

3. Participant is taking or intends to take any prostacyclin / prostacyclin (IP) analog or IP receptor agonist (except for treprostinil, inhaled [Tyvaso®]).

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lung Biotechnology PBC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beaumont Health

Troy, Michigan, United States

Albany Medical Center

Albany, New York, United States

The Mount Sinai Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The University of Toledo

Toledo, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Anderson Pharmaceutical Research, LLC

Anderson, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Scott & White Memorial Hospital

Temple, Texas, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Rabin Medical Center

Petah Tikva, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Countries

United States; Israel

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BPS-314d-MR-PAH-303

Identifier Type: -

Identifier Source: org_study_id