Status:
UNKNOWN
Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Primary Immunodeficiency Diseases (PID)
Eligibility:
All Genders
1-18 years
Brief Summary
In the prospective part of the study, patients diagnosed with PID will receive replacement therapy with Cutaquig for at least 6 months and will be randomised with the help of physicians of the Russian...
Detailed Description
In the prospective part of the study, patients diagnosed with PID will receive replacement therapy with Cutaquig for at least 6 months and will be randomised with the help of physicians of the Russian...
Eligibility Criteria
Inclusion
- Patients of both sexes over the age of 0 years with a verified diagnosis of primary immunodeficiency, who require regular immunoglobulin replacement therapy
- Patients' and/or their legal representatives' (for patients under 14 years of age) consent to participate in the study
Exclusion
- Hypersensitivity to the study drug or any component of the study drug
- Active oncological disease
- Condition after haematopoietic stem cell transplantation
- Use of other immunoglobulin products during the study drug therapy.
- Discontinuation or irregular use of the study drug
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05986734
Start Date
September 1 2022
End Date
December 1 2023
Last Update
August 14 2023
Active Locations (1)
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1
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117997