NCT07220915
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
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Record History
All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Minor Trial sites expanded: 17 → 25 locations
- Minor Trial sites expanded: 6 → 17 locations
- Eligibility criteria expanded, about 13 words
- Secondary endpoints: details revised at 2 of 3 entries
- Minor Trial sites expanded: 1 → 6 locationsv5
- Notable Recruitment opened
- Study sites: 0 to 1
- Start date changed from estimate of Jun 2026 to Jun 10, 2026
- Notable Start date: Dec 2025 to Jun 2026v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Secondary (3)
Arms and interventions
Panzyga is a 10% Ig formulation for intravenous (IV) administration. The product is delivered as a ready-to-use solution in glass bottles. Patients in the Panzyga treatment arm will receive 0.4 g/kg (4 mL/kg) per single infusion every 4 weeks for up to 48 weeks (up to 13 infusions). In the open-label phase patients will receive Panzyga 0.4 g/kg. If 3-4 weeks after the first open-label infusion the IgG trough level falls below 7 g/L, the dose will be increased to 0.6 g/kg. Additionally, the dose may be increased to 0.6 g/kg if a patient experiences one more major infection, or ≥2 other (non-major) infections.
4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion every 4 weeks for up to 48 weeks (up to 13 infusions).
Drugs: Panzyga, 10% Intravenous Solution
Other: Placebo
Sites
25 sites in 7 countries
United States 8, Czechia 4, Lithuania 4, Greece 3, Bulgaria 2, Latvia 2, Poland 2