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Trial record 1 of 20 for:    BEAT | Pulmonary Arterial Hypertension
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BPS-314d-MR-PAH-303 (BEAT OLE) (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 : Completed
First Posted : September 4, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Lung Biotechnology PBC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Beraprost Sodium 314d Modified Release tablets Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Treatment during the first 4 weeks of this study is double-blind. The investigator and study staff, the subjects, the monitors, and the sponsor will remain blinded to the treatment group allocation from BPS-314d-MR-PAH-302 study and to study drug during the first 4 weeks of the OLE study. 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: 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).
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)




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: Change in incidence from baseline to end of study, estimated up to 2 years. ]
    Descriptive analyses of all adverse events will be performed. Incidence will be described by the number of subjects analyzed and the percentage of those subjects who experienced an adverse event until study completion.

  2. Severity of treatment-related adverse events [ Time Frame: Change in incidence from baseline to end of study, estimated up to 2 years. ]

Secondary Outcome Measures :
  1. 6 Minute Walk Distance (6MWD) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]
    Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.

  2. Borg Dyspnea Score [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]
    The modified 0-10 category-ratio Borg scale is one in which the subjects rate the maximum level of dyspnea they experienced during the Six-Minute Walk Test (6MWT). Scores range from 0 (for the best condition) and 10 (for the worst condition).

  3. World Health Organization (WHO) Functional Class (FC) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]
    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.

  4. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]


Information from the National Library of Medicine

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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. 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.

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
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Sponsors and Collaborators
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
Last Update Posted: November 4, 2019
Last Verified: October 2019

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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