Status:
COMPLETED
A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)
Lead Sponsor:
AO GENERIUM
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A safety and immunogenicity study in long-term treatment of Eculizumab (JSC "GENERIUM", Russian Federation) in patients with paroxysmal nocturnal hemoglobinuria, who have been involved earlier in the ...
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
- Completion of participation in previous studies of Eculizumab (JSC "GENERIUM") while maintaining the clinical efficacy of the therapy with eculizumab.
- In case of significant deviations from the protocol during participation in previous studies, the decision on the possibility of patient participation in this study is made on an individual basis in agreement with the company Sponsor.
- Written informed consent to participate in this study.
- Documented vaccination against meningococcal infection (serotypes A, C, Y and W135 Neisseria meningitides) with an unexpired period of validity and consent of the patient to undergo booster vaccination against meningococcal infection (serotypes A, C, Y and W135 Neisseria meningitides) while participating in this research when the previous vaccination expires.
- Consent to use a reliable method of contraception (a combination of at least 2 methods, including 1 barrier method, for example, using a condom and spermicide), from the moment of signing the informed consent until 10 weeks after the last administration of the study drug.
Exclusion
- Hypersensitivity to the study drug, as well as to its components.
- Hypersensitivity to the active ingredients or any other component of the vaccine for the prevention of meningococcal infection, or a life-threatening reaction to the previous administration of a vaccine containing similar components.
- Comorbidities and conditions that, in the opinion of the Investigator, endanger the safety of the patient while participating in the study.
- Pregnancy or breastfeeding.
- Alcohol, drug or drug addiction.
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04679103
Start Date
May 3 2018
End Date
April 20 2020
Last Update
December 28 2020
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Chelyabinsk Oblast, Russia, 454076
2
Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
Kirov, Kirov Oblast, Russia, 610027
3
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov"
Saint Petersburg, Leningradskaya Oblast', Russia, 197022
4
Federal State Budgetary Institution "National Medical Research Center of Hematology" of the Ministry of Health of the Russian Federation
Moscow, Moscow Oblast, Russia, 125167