Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612268
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Research Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Global Phase 3 Randomised Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease
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:
Hibiscus 2
Brief Summary:
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs sickle cell pain crises caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease The study will also evaluate how well etavopivat can reduce the damage to different organs improve your exercise tolerance and reduce fatigue in people with sickle cell diseaseThe participants will either get etavopivat or placebo Which treatment the participants will get is decided by chance Etavopivat is a new medicine and is currently being tested in other studies in addition to this one The study will last for about 2 years
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