|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT04136028 |
|
Date of registration:
|
21/10/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
IL-1 Receptor Inhibitor for Granulomatous Complications in Patients With Chronic Granulomatous Disease
|
|
Scientific title:
|
A Retrospective Analysis of Efficacy and Safety of Interleukin-1 Receptor Inhibitor for the Treatment of Granulomatous Complications in Patients With Chronic Granulomatous Disease |
|
Date of first enrolment:
|
September 25, 2015 |
|
Target sample size:
|
13 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT04136028 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Early Phase 1
|
|
|
Countries of recruitment
|
|
Russian Federation
| | | | | | | |
|
Contacts
|
|
Name:
|
Anna Shcherbina, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Research Center for Pediatric Hematology , Moscow, Russian Federation |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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 Criteria:
- Patients, who do not meet the inclusion criteria.
- The reluctance of the patient or his legal representatives to participate in the
research.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Granulomatous Disease
|
|
Intervention(s)
|
|
Drug: Kineret
|
|
Primary Outcome(s)
|
|
overall survival
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
6 month-event-free survival
[Time Frame: 6 months]
|
|
3 month- event-free survival
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
NCPHOI-2019-05
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|