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A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension (BEAT OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657095
Recruitment Status : Terminated (The pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.)
First Posted : September 4, 2018
Results First Posted : August 20, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Lung Biotechnology PBC

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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Esuberaprost Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : July 20, 2019


Arm Intervention/treatment
Experimental: 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).
Drug: Esuberaprost
Sodium tablets
Other Name: Beraprost Sodium 314d Modified Release tablets

Placebo Comparator: 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).
Drug: Esuberaprost
Sodium tablets
Other Name: Beraprost Sodium 314d Modified Release tablets

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




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


Secondary Outcome Measures :
  1. Area Walked for the 6 Minute Walk Distance (6MWD) Test [ Time Frame: Week 4 and then every 3 months until study termination (Month 7) ]
    Area used for the Six Minute Walk Test (6MWT) were to be pre-measured at 30 meters in length. Rest periods were to be allowed if participant could no longer continue. If participant needed to rest, he/she could have stood or sit and then begin again when rested but the clock would continue to run. At the end of 6 minutes, the tester was to call "stop" while stopping the watch and then measure the distance walked. Distance <500 meters would have suggested considerable exercise limitation; distance 500-800 meters would have suggested moderate limitation; and distance >800 meters (with no rests) would have suggested mild or no limitation. This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed.

  2. Borg Dyspnea Score [ Time Frame: Week 4 and then every 3 months until study termination (Month 7) ]
    The modified 0-10 category-ratio Borg scale is one in which the participants were to rate the maximum level of dyspnea they experienced during the 6MWT. Scores would have ranged from 0 (for the best condition) and 10 (for the worst condition). This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed. Note, a summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

  3. 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) ]
    The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed.

  4. Number of Participants With a TEAE of N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP) Increased [ Time Frame: Baseline up to Month 7 ]
    A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657095


Locations
Show Show 45 study locations
Sponsors and Collaborators
Lung Biotechnology PBC
  Study Documents (Full-Text)

Documents provided by Lung Biotechnology PBC:
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Responsible Party: Lung Biotechnology PBC
ClinicalTrials.gov Identifier: NCT03657095    
Other Study ID Numbers: BPS-314d-MR-PAH-303
First Posted: September 4, 2018    Key Record Dates
Results First Posted: August 20, 2020
Last Update Posted: September 7, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung Biotechnology PBC:
Hypertension
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Prostacyclin
Beraprost
Epoprostenol
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Beraprost
Platelet Aggregation Inhibitors
Vasodilator Agents