Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04370054
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2020-04-21
Brief Title:
Study to Evaluate the Efficacy and Safety of PF-07055480 Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase 3 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 Recombinant AAV26 Human Factor VIII Gene Therapy in Adult Male Participants With Moderately Severe to Severe Hemophilia AFVIIIC1
Status:
ACTIVE_NOT_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:
AFFINE
Brief Summary:
C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 giroctocogene fitelparvovec Recombinant AAV26 Human Factor VIII Gene Therapy in adult male participants with moderately severe or severe hemophilia A FVIIIC1 for the study duration of 5 years The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004
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 |
|---|---|---|---|
| 2019-004451-37 | EUDRACT_NUMBER | None | None |