Status and phase
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About
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
Enrollment
Sex
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Inclusion and exclusion criteria
Criteria for inclusion:
Written informed consent/assent obtained from subjects/subjects' parent(s) or legally acceptable representative indicating that they understood the purpose of, and procedures required for the study and are willing to participate in it.
Male or female, aged 2 through 75 years, inclusive.
Diagnosis of PID with impaired antibody production, ie:
Or
Established replacement therapy with any immunoglobulin for intravenous administration (IVIg) reference preparation during the previous 6 months, including documentation of IgG trough levels.
Established replacement therapy with a single IVIg reference preparation for ≥3 months prior to treatment start with BT595 at a 3 week (Q3W) or 4 week (Q4W) schedule with a constant IVIg dose that did not change by ±20% of the mean dose, regular dosage intervals, and at least 1 IgG trough level of ≥5 g/L during the previous 3 months.
Criteria for exclusion:
Primary purpose
Allocation
Interventional model
Masking
81 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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