A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID)

Phase 1

• Conditions: PID (Primary Immunodeficiency); MedDRA version: 9.1Level: LLTClassification code 10064859Term: Primary immunodeficiency syndrome

• Registration Number: EUCTR2006-006745-13-PL
• Lead Sponsor: CSL Behring

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-11
• Study Completion: 2009-08-31
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

· Male or female aged > 24 months and £ 65 years
· Subjects with primary humoral immunodeficiency, namely with a
diagnosis of
o CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies)
o or XLA as defined by PAGID and ESID
o or Autosomal Recessive Agammaglobulinemia
· Subjects who have received
o IVIG therapy at regular 3- or 4-week intervals
o or SCIG therapy at regular weekly intervals at a stable dose (variations of ± 10% are allowed) for at least 6 months prior to receiving IgPro20 (maintenance dose to reach a
cumulative monthly dose of the order of 0.2 – 0.8 g/kg)
· At least 3 documented IgG trough levels of = 5 g/L during 3 months on IVIG or SCIG replacement therapy immediately prior to receiving IgPro20; 2 of the 3 IgG trough levels may go back up to 6 months prior to receiving IgPro20, in case of stable dosing
for at least 3 months prior to this assessment
· Chest X-ray or CT Scan obtained within 1 year prior to
enrollment
· Women of childbearing potential using medically approved contraception and having a negative pregnancy test at screening
· Written informed consent

Inclusion criteria for PK assessment
· Male or female aged = 6 years
· Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Newly diagnosed PID, i.e. subjects who have not previously
received immunoglobulin replacement therapy
· Ongoing serious bacterial infection at the time of screening
· Malignancies of lymphoid cells such as lymphocytic leukemia,
Non-Hodgkin’s lymphoma and immunodeficiency with thymoma
· Known hyperprolinemia
· Hypoalbuminemia, protein- losing enteropathies, and any
proteinuria (defined by total urine protein concentration > 0.2
g/L)
· Allergic or other severe reactions to immunoglobulins or other
blood products associated with high anti-IgA
· The subject is receiving steroids (oral and parenteral, daily = 0.15
mg of prednisone equivalent/kg/day) or other systemic
immunosuppressants
· Females who are pregnant, breast feeding or planning a
pregnancy during the course of the study
· A positive result at screening on any of the following viral
markers: HIV, HCV or HBV
· ASAT or ALAT concentration > 2.5 times Upper Limit of
Normal Range (ULNR)
· Creatinine concentration > 1.5 times ULNR
· Participation in a study with an investigational product other than
immunoglobulin within 3 months prior to enrollment
· Evidence of uncooperative attitude
· Any condition that is likely to interfere with evaluation of the
study drug or satisfactory conduct of the trial
· Patients who are employees at the investigational site, relatives or
spouse of the investigator

Study & Design

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