Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749810
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2021-02-08
Brief Title:
Observational Study of Elizaria in aHUS Patients
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria in Patients With Atypical Hemolytic Uremic Syndrome
Status:
COMPLETED
Status Verified Date:
2022-02
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:
It is a multicenter observational non-comparative study of the efficacy and safety of long-term pathogenetic Elizaria therapy in patients with atypical Hemolytic Uremic Syndrome
Detailed Description:
After screening patients meeting all of the inclusion non-inclusion criteria and vaccinated against meningococcal infections were treated by Elizaria
The study is planned to include at least 50 patients receiving Elizaria for the aHUS treatment
The study will consist of a screening period of up to 4 weeks including if necessary immunization with meningococcal vaccine a treatment period of 52 weeks
Medication will be prescribed in accordance with routine medical practice Accordingly to minimize the risks and subjectivity of assessments the methods adopted in the routine practice of treating patients with aHUS will be used
Investigators enroll patients with aHUS diagnosis who have indications for pathogenetic therapy and who are receiving Elizaria under the government program Patients will receive medication in accordance with the established requirements of national standards and protocols for the treatment of patients with aHUS The registration of the amount of the drug used will be carried out on the basis of information in the Patient Diaries as well as primary documentation
The study is planned to include at least 50 patients receiving Elizaria for the aHUS treatment
The study will consist of a screening period of up to 4 weeks including if necessary immunization with meningococcal vaccine a treatment period of 52 weeks
Medication will be prescribed in accordance with routine medical practice Accordingly to minimize the risks and subjectivity of assessments the methods adopted in the routine practice of treating patients with aHUS will be used
Investigators enroll patients with aHUS diagnosis who have indications for pathogenetic therapy and who are receiving Elizaria under the government program Patients will receive medication in accordance with the established requirements of national standards and protocols for the treatment of patients with aHUS The registration of the amount of the drug used will be carried out on the basis of information in the Patient Diaries as well as primary documentation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None