Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients (NCT03961009) | Clinical Trial Compass
CompletedPhase 3
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
United States47 participantsStarted 2019-04-30
Plain-language summary
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Who can participate
Age range2 Years – 70 Years
SexALL
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Inclusion Criteria:
* Written informed consent/assent obtained from participant/participant's parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it.
* Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and have documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes \[that is at least 2 standard deviations under the mean level per age\])
* Male or female, ages 2 to 70 years at screening
* Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21- or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusion cycles prior to screening
* At least 2 documented IgG trough levels while receiving an IVIg, of greater than or equals to (\>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months (1 must be within 6 months) prior to Informed Consent Form (ICF) signature
* Participant is willing to comply all requirements of the protocol.
* Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study
* Authorization to access personal health information
* Participant previously participating in a clinical trial with another experimental IVIg may be enrolled if they have received stable commercially avai…
What they're measuring
1
Incidence Rate of Acute Serious Bacterial Infections (ABSIs)
Timeframe: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)