Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03657095
Status:
TERMINATED
Last Update Posted:
2020-09-07
First Post:
2018-05-18
Brief Title:
A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The pivotal study BPS-314d-MR-PAH-302 NCT01908699 failed to demonstrate efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAT OLE
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 Investigators or designees 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
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 Investigators or designees 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None