Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-65
SponsorVirchow Group
About this trial
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
Eligibility criteria
Qualifiers
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.
WBC ≥3.5 x 109/L
Disqualifiers
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
Trial design
Treatments tested in this trial
- IVIG-VImmune
- IVIG-Immuglo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov