Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609226
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multi-centre Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORAL
Brief Summary:
Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin Haemoglobin is the protein that carries oxygen through the body This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time The study will last for up to 264 weeks but it will end earlier if etavopivat is approved in the participants country
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