Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255977
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-12-24
Brief Title:
A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral Hemorrhage
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
A Multicenter Randomized Blind Placebo-controlled Dose-finding Phase II Trial Evaluating the Safety and Efficacy of the Neuroprotective Peptide CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage CN-CATCH
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Intracerebral hemorrhage ICH is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes Apolipoprotein E apoE has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses We developed a 5-amino acid peptide CN-105 that mimics the polar face of the apoE helical domain involved in receptor interactions readily crosses the blood-brain barrier and improves outcomes in well-established preclinical ICH models In the current study aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages
Detailed Description:
Inclusion Patients with spontaneous acute supratentorial intracerebral hemorrhage confirmed by CTage 30 to 80 yearsIntravenous infusion with CN-105 peptide for injection every 6 hours up to a maximum of 13 doses within 72 hours
Blood samples for protein markers will be collected and detected at screening 48 hD3 and 120 hD6 after the first dose
The sample size is 240
Blood samples for protein markers will be collected and detected at screening 48 hD3 and 120 hD6 after the first dose
The sample size is 240
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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