A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-006745-13-DE
• Date of registration: 21/03/2007
• Prospective Registration: Yes
• Primary sponsor: CSL Behring AG
• Public title: A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency
• Scientific title: A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency
• Date of first enrolment: 11/07/2007
• Target sample size: 51
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006745-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
· Male or female aged > 24 months and < 65 years
· Subjects with primary humoral immunodeficiency, namely with a diagnosis of
- CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies (16))
- or XLA as defined by PAGID and ESID (16)
- or Autosomal Recessive Agammaglobulinemia
· Subjects who have received
- IVIG therapy at regular 3- or 4-week intervals
- 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 SUBSTUDY
· 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) yes
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 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




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

Health Condition(s) or Problem(s) studied

PID (Primary Immunodeficiency)
MedDRA version: 9.1 Level: LLT Classification code 10064859 Term: Primary immunodeficiency syndrome

Intervention(s)

Product Name: IgPro20
Product Code: IgPro20
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunglobulin G (IgG)
Concentration unit: % percent
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: Secondary efficacy objectives of the study are the rate of clinically documented serious bacterial infections, the number of infection episodes, the number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, the number of days of hospitalization due to infections, and the use of antibiotics for infection prophylaxis and treatment.
Safety objectives of this study are monitoring of short-term tolerance (blood pressure, heart rate, body temperature), the local tolerability of subcutaneous infusions, monitoring of adverse events, vital sign changes before and after infusions at the study site, and changes in routine laboratory parameters as compared to baseline assessments.

Main Objective: The primary objective of this study is to achieve sustained total serum IgG trough levels comparable to the previous IgG treatment in the ITT population. This will be evaluated from a descriptive comparison of three trough levels measured during previous treatment prior to the study with six consecutive trough levels measured at a steady state period within the study.

Primary end point(s): The primary variable of this study is to descriptively compare IgG trough levels at 6 consecutive weeks at steady state within the study, i.e. IgG levels prior to infusions 12 to 17, with 3 trough levels obtained from the subject’s previous treatment during the last 3 to 6 months prior to the study.

Secondary ID(s)

ZLB06_001CR