Primary Immunodeficiency Diseases Clinical Trial
Official title:
Evaluation of an IgG Deficiency Rapid Screening Test (RDT) With Human Capillary Samples: A Protocol to Generate RDT Performance Data in Primary Immunodeficiency Patients (PID)
Verified date | March 2024 |
Source | PATH |
Contact | Megan Parker |
Phone | 202.460.6239 |
mparker[@]path.org | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | Inclusion Criteria: - Must be 6 months of age. - The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) | 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM). Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Tunisia | National Bone Marrow Transplant center | Tunis |
Lead Sponsor | Collaborator |
---|---|
PATH | Bill and Melinda Gates Foundation, Centre National de Greffe de Moelle Osseuse, Institut Pasteur de Tunis |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment. | - Did the test run correctly when following the IFU?
•Was the end user (nurse) able to interpret a test result for the patient from the investigational PID RDT (positive, negative) with valid control using a patient's capillary finger prick sample? |
3 month | |
Primary | To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma). | What is the % agreement between the PID RDT run on capillary blood (Capillary Test A) and the referent assay run on plasma/serum? | 3 months | |
Secondary | To determinethe utility of the PID RDTwith PID patients. | Can the investigational PID RDT be used with a finger prick (capillary) blood sample among study participants?
Was the finger prick blood sample successfully collected from the finger and transferred to the PID RDT?•Did the test run complete and give a valid result when run according to instructions? Could a result be interpreted from the PID RDT? |
3 months | |
Secondary | To determine% agreement between capillary and venous blood samples using the PID RDT | What is the % agreement between fresh capillary blood and fresh venous blood using the PID RDT? | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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