Status:
COMPLETED
Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®
Lead Sponsor:
AO GENERIUM
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Brief Summary
This is prospective observational study of long-term pathogenic treatment of Elizaria® in patients with paroxysmal nocturnal hemoglobinuria.
Detailed Description
Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, acquired, life-threatening, progressive clonal blood disease that is developed as a result of the expansion of one or more clones of hematop...
Eligibility Criteria
Inclusion
- Male and female patients aged 2 years with an established diagnosis of PNH;
- Prescribing Elizaria® as a pathogenetic therapy;
- Signing by the patient of the informed consent form for participation in the study.
Exclusion
- 1\. Intolerance to eculizumab or other components of the drug.
Key Trial Info
Start Date :
June 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04671810
Start Date
June 13 2019
End Date
May 5 2023
Last Update
September 13 2023
Active Locations (8)
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1
State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Chelyabinsk Oblast, Russia, 454076
2
State Budgetary Institution of Healthcare Irkutsk Order of the "Badge of Honor" Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, Russia, 644079
3
State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.P. Botkin of the Moscow Department of Health
Moscow, Moscow Oblast, Russia, 125284
4
Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation on the basis of the State Budgetary Institution of Health of the Novosibirsk Region "City Clinic
Novosibirsk, Novosibirsk Oblast, Russia, 630091