NCT04749810

Observational Study of Elizaria® in aHUS Patients

Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Atypical Hemolytic Uremic Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: —

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.

Conditions

• Atypical Hemolytic Uremic Syndrome
• aHUS

Interventions

Type	Name	Description
DRUG	Elizaria®	Induction cycle: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 1200 mg (4 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 1200 mg every 14 days.

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-02-28
• Completion: 2022-04-30
• First posted: 2021-02-11
• Last updated: 2022-08-04

Locations

8 sites across 1 country: Russia