Observational Study of Elizaria in aHUS Patients

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    AO GENERIUM
Updated on 5 July 2022

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

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.

Details
Condition Atypical Hemolytic Uremic Syndrome, ahus
Treatment Elizaria®
Clinical Study IdentifierNCT04749810
SponsorAO GENERIUM
Last Modified on5 July 2022

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