Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541628
Status:
TERMINATED
Last Update Posted:
2024-01-24
First Post:
2020-08-21
Brief Title:
Safety Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 12 Open-Label Dose-Escalation Safety Tolerability and Efficacy Study of SIG-001 in Adult Patients With Severe or Moderately-Severe Haemophilia A Without Inhibitors SIG-001-121
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SIG-001 programme terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SIG-001-121 is a first-in-human FIH phase 12 multi-centre open-label dose escalation study to assess the safety tolerability and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors Up to three dose cohorts 3 patients each are planned Cohort expansions up to 3 additional patients may be triggered to collect additional information about safety and efficacy
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