Primary immunodeficiency MedDRA version: 19.1 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Privigen
Product Name: Privigen
immunoglobulin intravenous (human)
Product Code: IgPro10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Sponsors
CSL Behring KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female Japanese subject with a diagnosis of PID. 2. Aged = 6 years with body weight = 19 kg at the time of providing written informed consent/minor assent. 3. Previously receiving stable doses of any intravenous immunoglobulin (IVIG) product currently approved in Japan for at least 6 months prior to study entry at regular 3- or 4-weekly intervals. 4. At least 1 historic IgG trough level of = 5 g/L during the past 6 months prior to study entry (can be obtained at Screening). Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed PID. 2. Ongoing active serious infection at the time of Screening (e.g., pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess). 3. Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma and immunodeficiency with lymphoma. 4. Known hyperprolinemia, hypoalbuminemia, protein-losing enteropathies, and any proteinuria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the PK of IgG following intravenous IgPro10 dosing in Japanese PID subjects after a standard wash-in/wash-out period of 12 weeks.;Secondary Objective: To collect safety information about the use of IgPro10 in Japanese PID subjects.;Primary end point(s): 1. Minimum concentration (Cmin) of IgG following intravenous IgPro10 dosing 2. Maximum concentration (Cmax) of IgG following intravenous IgPro10 dosing 3. Time to reach maximum concentration (Tmax) of IgG following intravenous IgPro10 dosing 4. Area under the concentration-time curve from time zero to the last sample (AUC0-last) following intravenous IgPro10 dosing 5. Total body clearance (CL) of IgG following intravenous IgPro10 dosing;Timepoint(s) of evaluation of this end point: 1-5. Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects with adverse events (AEs);Timepoint(s) of evaluation of this end point: Up to 4 months after first infusion of IgPro10 | — |
Countries
Japan
Contacts
Public ContactTrial Registration Coordinator
CSL Behring
Outcome results
None listed