Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02193334
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2014-06-27
Brief Title:
Phase III Study of KP-100IT in Acute Spinal Cord Injury
Sponsor:
Kringle Pharma Inc
Organization:
Kringle Pharma Inc
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2019-06
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 study is randomized double-blind placebo-controlled Phase III study designed to evaluate safety and efficacy of KP-100IT code of Hepatocyte Growth Factor HGF formulation for intrathecal injection as a treatment for acute spinal cord injury The study is conducted at two clinical sites in Japan
Detailed Description:
None
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