Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321705
Status:
AVAILABLE
Last Update Posted:
2024-03-20
First Post:
2024-03-14
Brief Title:
Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension
Sponsor:
Cereno Scientific AB
Organization:
Cereno Scientific AB
Study Overview
Official Title:
Expanded Access Open-Label Safety Extension Study for Patients That Have Completed Parent Study CS1-003 and Who Are Judged by the Investigator to Benefit From Continued CS1 Treatment
Status:
AVAILABLE
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CS1-004 will be an extension of the CS1-003 Study The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1
Detailed Description:
CS1-004 will be an extension of the CS1-003 Study The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1 The exploratory objectives are to evaluate clinical benefit by using Cardio-Microelectromechanical system CardioMEMS echocardiography cardiac magnetic resonance imaging right heart catheterization quality of life assessments and actigraphy to measure changes in clinical response with continued treatment with CS1 in patients with Pulmonary Arterial Hypertension PAH
Up to 30 patients are planned for enrollment in the ongoing phase 2 Study CS1-003 thus up to 30 patients could participate in Study CS1-004 if they completed the parent study tolerated CS1 treatment and in the investigators judgement the benefits of continued treatment with CS1 outweigh the risk Note that as the parent study is ongoing thus some patients will directly roll- over into Study CS1-004 with no disruption in CS1 treatment while other patients that have already completed Study CS1-003 will need to be restarted on CS1 On a yearly basis the principal investigator will determine if a patient continues the expanded access study for a subsequent year based on safety tolerability and clinical benefit of CS1 Continuation of the expanded access study will also be evaluated on a yearly basis by Cereno Scientific Sponsor
Up to 30 patients are planned for enrollment in the ongoing phase 2 Study CS1-003 thus up to 30 patients could participate in Study CS1-004 if they completed the parent study tolerated CS1 treatment and in the investigators judgement the benefits of continued treatment with CS1 outweigh the risk Note that as the parent study is ongoing thus some patients will directly roll- over into Study CS1-004 with no disruption in CS1 treatment while other patients that have already completed Study CS1-003 will need to be restarted on CS1 On a yearly basis the principal investigator will determine if a patient continues the expanded access study for a subsequent year based on safety tolerability and clinical benefit of CS1 Continuation of the expanded access study will also be evaluated on a yearly basis by Cereno Scientific Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None