Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03542760
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2018-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acquired Methemoglobinemia Observational Registry
Sponsor:
Hospital Quality Foundation
Organization:
Study Overview
Official Title:
Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
Status:
COMPLETED
Status Verified Date:
2023-04
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:
metHb
Brief Summary:
This prospective, observational registry aims to collect real-world data regarding the safety and efficacy of ProvayBlue® (methylene blue 0.5%) used according to normal standard of care for the treatment of acquired methemoglobinemia. Methylene blue has been used for decades as a rescue medication for the treatment of methemoglobinemia, a rare and potentially life-threatening condition in which elevated levels of methemoglobin impede the delivery of oxygen from blood to body tissues. However, consistent prospective data about the safety and efficacy of this medication are sparse, simply because of the rarity of the disorder. ProvayBlue® received accelerated FDA approval for treatment of acquired methemoglobinemia in 2016. This large, prospective, multi-center observational registry has been initiated to gain more information on the use of methylene blue in the treatment of acquired methemoglobinemia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: