The pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2016-001631-12-Outside-EU/EEA
• Date of registration: 30/01/2017
• Prospective Registration: Yes
• Primary sponsor: CSL Behring KK
• Public title: The pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency
• Scientific title: Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency
• Target sample size: 10
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001631-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Japan

Contacts

• Name: Trial Registration Coordinator
• Affiliation: CSL Behring

• Name: Trial Registration Coordinator
• Affiliation: CSL Behring

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary immunodeficiency
MedDRA version: 19.1 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 4 months after first infusion of IgPro10

Secondary end point(s): Percentage of subjects with adverse events (AEs)

Secondary ID(s)

IgPro10_3004

Source(s) of Monetary Support

CSL Behring KK