Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients (NCT07017036) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients
India44 participantsStarted 2025-07-01
Plain-language summary
The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for follow-up assessments
Who can participate
Age range2 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 2 to 65 years.
✓. Patients with confirmed diagnosis of primary immunodeficiency, predominantly antibody deficient, or common variable immunodeficiency (CVID) with a history of hypogammaglobulinemia (i.e., IgG\<500 mg/dl) or X-linked agammaglobulinemia (XLA).
✓. Treatment naive patients eligible to receive intravenous immunoglobulin or, patients already on intravenous immunoglobulin infusions every 3 or every 4 weeks for ≥6 months at a dose aimed to be between 200 and 800 mg/kg with at least two documented IgG trough levels in the previous two infusions before enrolment in the study.
✓. The screening laboratory tests must meet the following criteria:
✓. WBC ≥3.5 x 109/L
✓. Neutrophils ≥1.5 x 109/L
✓. Platelets ≥100 x 109/L
✓. Serum transaminase ≤2 times the upper limit of normal
Exclusion criteria
✕. Pregnant women, nursing mothers or a planned pregnancy within 18 months of participation.
✕. Patients requires any blood transfusion during the study.
✕. Patients with T-cell related Severe combined immunodeficiency.
✕. Patients with secondary immunodeficiency diseases
What they're measuring
1
Primary - Incidence of acute serious bacterial infections