Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297486
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-02-29
Brief Title:
Study of a Gene Therapy Treatment for Hemophilia A
Sponsor:
Spark Therapeutics Inc
Organization:
Spark Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Single-arm Open-label Multicenter Study of the Safety and Efficacy of Dirloctocogene Samoparvovec SPK 8011 Adeno-associated Viral Vector With B-domain Deleted Human Factor VIII Gene in Adults With Severe or Moderately Severe Hemophilia A
Status:
RECRUITING
Status Verified Date:
2024-07
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:
KEYSTONE 1
Brief Summary:
The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504537-46 | EUDRACT_NUMBER | None | None |