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Clinical trial

Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Paroxysmal Nocturnal Hemoglobinuria.

ID
Name
ECU-PNH-N01
Description
This is prospective observational study of long-term pathogenic treatment of Elizaria® in patients with paroxysmal nocturnal hemoglobinuria.
Trial arms
Trial start
2019-06-13
Estimated PCD
2022-12-28
Trial end
2023-05-05
Status
Completed
Treatment
Elizaria®
Elizaria® will be prescribed by the Physician according to the actual SMPC.
Other names:
Eculizumab
Size
44
Primary endpoint
Dynamics of the peripheral blood LDH level during 52 weeks of the maintenance stage of treatment with Elizaria® (between Visits 6 and 13, inclusive).
52-56 weeks
Eligibility criteria
Inclusion Criteria: 1. Male and female patients aged 2 years with an established diagnosis of PNH; 2. Prescribing Elizaria® as a pathogenetic therapy; 3. Signing by the patient of the informed consent form for participation in the study. Exclusion Criteria: 1. Intolerance to eculizumab or other components of the drug.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

1 product

1 indication

Organization
AO Generium
Product
Elizaria®
Indication
Paroxysmal Nocturnal Hemoglobinuria