TBI-001-IGIV– A prospective, open-label, multicenter study of the efficacy, safety, tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases. A Phase 3 trial, duration 1 year.
Quick Glance on Inclusion/Exclusion Criteria(s) ↓
- Age, 2-70 years of old
- Confirmed diagnosis of a PIDD which requires treatment with IGIV.
- Hyper-IgM Syndrome (HIGM) with documented IgG levels < 500 mg/dL Must have received IGIV therapy at 21 or 28 days intervals for at least three consecutive months at a stable dose between 300-900 mg/kg/infusion (without having a ≥ 25% change in dose) prior to screening
- No bacterial infection or viral infection within 7 days prior to baseline or is receiving antibiotic treatment
- No secondary immunodeficiency Subject must have not received IMP under investigation within the past 30 days at the time of baseline
- NO positive NAT, HIV -1 or HIV-2, Hepatitis B (HBV) and C (HCV), Anemia 3 times the ULN eGFR must be >60
- Must have not received other immunosuppressive or immunomodulatory drugs or chemotherapy
- No Prednisone within 10 days prior to screening