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

Phase 1

• Conditions: Primary immunodeficiency; MedDRA version: 19.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001631-12-Outside-EU/EEA
• Lead Sponsor: CSL Behring KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified