Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145373
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-11-17
Brief Title:
A Study to Test a Medicine Fitusiran for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open-label Single-arm Treatment Study to Investigate the Safety and Tolerability of Switching From Emicizumab to Fitusiran Prophylaxis in Male Participants Aged 18 Years of Age With Severe Hemophilia A With or Without Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-03
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 is an exploratory single group Phase 1 1-arm study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis
This study aims to evaluate the safety and tolerability of switching to fitusiran after a transition period from the last dose of emicizumab The study will be conducted in male participants with severe hemophilia A with or without inhibitors aged 18 years who were previously receiving emicizumab prophylaxis
Study details include
The study duration will be up to approximately 28 months
There will be an approximately 2-month screening period
There will be a transition period before fitusiran treatment starts pre-fitusiran treatment period
The fitusiran treatment duration will be up to 18-months fitusiran treatment period
The antithrombin AT follow-up FU period will be up to 6 months after the last dose of fitusiran during which the AT activity level will be monitored at approximately monthly intervals following the final fitusiran dose until AT activity levels return to at least 60
The study site visits are scheduled at monthly every 2 months intervals of 28 days 4 weeks 56 days 8 weeks respectively during the fitusiran treatment period
This study aims to evaluate the safety and tolerability of switching to fitusiran after a transition period from the last dose of emicizumab The study will be conducted in male participants with severe hemophilia A with or without inhibitors aged 18 years who were previously receiving emicizumab prophylaxis
Study details include
The study duration will be up to approximately 28 months
There will be an approximately 2-month screening period
There will be a transition period before fitusiran treatment starts pre-fitusiran treatment period
The fitusiran treatment duration will be up to 18-months fitusiran treatment period
The antithrombin AT follow-up FU period will be up to 6 months after the last dose of fitusiran during which the AT activity level will be monitored at approximately monthly intervals following the final fitusiran dose until AT activity levels return to at least 60
The study site visits are scheduled at monthly every 2 months intervals of 28 days 4 weeks 56 days 8 weeks respectively during the fitusiran treatment period
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 |
|---|---|---|---|
| 2022-502414-84 | REGISTRY | None | None |
| U1111-1280-7227 | REGISTRY | ICTRP | None |