Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099236
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-09-29
Brief Title:
A Prospective Non-interventional Observational Study of Presentation Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Prospective Non-interventional Observational Study of Presentation Treatment Patterns and Outcomes in Chinese Atypical Hemolytic Uremic Syndrome Patients
Status:
RECRUITING
Status Verified Date:
2024-10
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 a China non-interventional observational study and will follow the Good Phar-macoepidemiology Practices guidelines
This study will enrol paediatric and adult patients diagnosed with aHUS who will be treated according to routine clinical practice defined by local institutional treatment guidelinesprotocol Those aHUS patients who will be treated with a supportive therapy which does not contain eculizumab will be monitored for up to 12 months since the ini-tial diagnosis Patients initiated on eculizumab treatment anytime between aHUS diagno-sis until 12 months will be followed for additional 12 months starting from the ecu initia-tion Patient disposition characteristics outcomes and safety will be described for all pa-tients enrolled into this study
This study will enrol paediatric and adult patients diagnosed with aHUS who will be treated according to routine clinical practice defined by local institutional treatment guidelinesprotocol Those aHUS patients who will be treated with a supportive therapy which does not contain eculizumab will be monitored for up to 12 months since the ini-tial diagnosis Patients initiated on eculizumab treatment anytime between aHUS diagno-sis until 12 months will be followed for additional 12 months starting from the ecu initia-tion Patient disposition characteristics outcomes and safety will be described for all pa-tients enrolled into this study
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