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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03657095
• Date of registration: 18/05/2018
• Prospective Registration: Yes
• Primary sponsor: Lung Biotechnology PBC
• Public title: A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension BEAT OLE
• Scientific title: An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients
• Date of first enrolment: December 10, 2018
• Target sample size: 112
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03657095
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Israel, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Placebo

Drug: Esuberaprost

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: Baseline up to Month 7]

Secondary Outcome(s)

Area Walked for the 6 Minute Walk Distance (6MWD) Test [Time Frame: 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) [Time Frame: 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 [Time Frame: Baseline up to Month 7]

Borg Dyspnea Score [Time Frame: Week 4 and then every 3 months until study termination (Month 7)]

Secondary ID(s)

BPS-314d-MR-PAH-303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03657095