Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05224531
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2022-01-17
Brief Title:
Effect of CS1 in Subjects With Pulmonary Arterial Hypertension
Sponsor:
Cereno Scientific AB
Organization:
Cereno Scientific AB
Study Overview
Official Title:
A Phase 2 Prospective Randomized Open-label Blinded Endpoint Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics and Exploratory Efficacy of 3 Doses of CS1 in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a Phase 2 parallel group study to evaluate the safety tolerability PK and exploratory efficacy of 3 doses of CS1 in the treatment of PAH using the CardioMEMS HF System to obtain repeated measurements of PAP and other hemodynamic parameters
Elegible subjects will have a RHC to implant the CardioMEMS pulmonary artery PA Sensor followed by a Baseline Period for the subject to become familiar with the system its measurements how to send the data and establish Baseline PA pressure Alternately the subject may already have the CardioMEMS HF System and is willing to have the system recalibrated in conjunction with RHC Thereafter the subject will be randomly assigned to 1 of 3 total daily doses of CS1 111 there will be 10 subjects assigned to each dose level Subjects will receive study drug treatment for 12 weeks During the study mPAP and other hemodynamic parameters from CardioMEMS PA Sensor will be measured and data captured once daily in the morning before the subject gets out of bed
The data will be transferred electronically to a repository The analysis will look at the area under the curve AUC of mPAP and the doses will be compared to each other regarding change from Baseline In addition to the CardioMEMS HF System measurements the subjects will be followed for mortality and morbidity important biomarkers as well as subjective functional and structural parameters of importance for PAH for the duration of the study
Subjects will be enrolled for up to 22 weeks a Screening Period of up to 2 weeks prior to the start of the Baseline Period a Baseline Period of up to 6 weeks prior to Randomization a Treatment Period of 12 weeks and a Follow-up Period of 2 weeks
The primary objective of the study is to obtain safety and tolerability data
Elegible subjects will have a RHC to implant the CardioMEMS pulmonary artery PA Sensor followed by a Baseline Period for the subject to become familiar with the system its measurements how to send the data and establish Baseline PA pressure Alternately the subject may already have the CardioMEMS HF System and is willing to have the system recalibrated in conjunction with RHC Thereafter the subject will be randomly assigned to 1 of 3 total daily doses of CS1 111 there will be 10 subjects assigned to each dose level Subjects will receive study drug treatment for 12 weeks During the study mPAP and other hemodynamic parameters from CardioMEMS PA Sensor will be measured and data captured once daily in the morning before the subject gets out of bed
The data will be transferred electronically to a repository The analysis will look at the area under the curve AUC of mPAP and the doses will be compared to each other regarding change from Baseline In addition to the CardioMEMS HF System measurements the subjects will be followed for mortality and morbidity important biomarkers as well as subjective functional and structural parameters of importance for PAH for the duration of the study
Subjects will be enrolled for up to 22 weeks a Screening Period of up to 2 weeks prior to the start of the Baseline Period a Baseline Period of up to 6 weeks prior to Randomization a Treatment Period of 12 weeks and a Follow-up Period of 2 weeks
The primary objective of the study is to obtain safety and tolerability data
Detailed Description:
None
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