Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587464
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
A Study to Explore Hereditary Angioedema HAE Symptoms and Treatment Patterns in Korean People
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring Symptom Profile and Treatment Patterns in Korean HAE Patients Using Digital Patient Diary A Retrospective Descriptive Study SPEAKUP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SPEAKUP
Brief Summary:
This study intends to gather information on HAE attack symptoms how often the attacks occur and the number of times treatment is required to manage the attacks in Korean people over a period of up to 8 months
The main aims of this study are the following
To describe the patterns of HAE attacks including how often they occur where they happen in the body how severe they are the time between attacks and any warning signs that appear before an attack
To assess how HAE is treated particularly looking at how on-demand treatments are used during HAE attacks
To learn about the people who suffer from HAE attacks eg age gender for how long they have been suffering from HAE and if they use danazol to manage HAE
In this study already existing data will be collected and reviewed from a mobile application called MyHAE Story The study will only review data collected as part of the clinical routine practice The study will not impact the standard medical care and treatment of participants
The main aims of this study are the following
To describe the patterns of HAE attacks including how often they occur where they happen in the body how severe they are the time between attacks and any warning signs that appear before an attack
To assess how HAE is treated particularly looking at how on-demand treatments are used during HAE attacks
To learn about the people who suffer from HAE attacks eg age gender for how long they have been suffering from HAE and if they use danazol to manage HAE
In this study already existing data will be collected and reviewed from a mobile application called MyHAE Story The study will only review data collected as part of the clinical routine practice The study will not impact the standard medical care and treatment of participants
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