Status:
COMPLETED
IL-1 Receptor Inhibitor for Granulomatous Complications in Patients With Chronic Granulomatous Disease
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Chronic Granulomatous Disease
Eligibility:
All Genders
Up to 18 years
Phase:
EARLY_PHASE1
Brief Summary
"Kineret" (INN: Anakinra) neutralizes the biological activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by the concurrent inhibition of binding to interleukin-1 receptor I (IL-1RI). Interle...
Detailed Description
The research will include a group of patients with a molecular-genetic confirmed diagnosis of chronic granulomatous disease, which has granulomatous complications on the basis of an initial comprehens...
Eligibility Criteria
Inclusion
- Granulomatous changes in the lungs or liver according to CT scan.
- Negative galactomannan and lack of microorganism growth in bronchoalveolar lavage and/or lack of response to complex antibacterial and antifungal therapy for two to three weeks.
- Signed informed consent
Exclusion
- Patients, who do not meet the inclusion criteria.
- The reluctance of the patient or his legal representatives to participate in the research.
Key Trial Info
Start Date :
September 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04136028
Start Date
September 25 2015
End Date
January 1 2020
Last Update
April 7 2020
Active Locations (1)
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1
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117198