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 range
2 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary - Incidence of acute serious bacterial infections