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

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2008-000830-30-SE
• Date of registration: 03/11/2008
• Prospective Registration: Yes
• Primary sponsor: CSL Behring AG
• Public title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study)
• Scientific title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study)
• Date of first enrolment: 17/12/2008
• Target sample size: 36
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000830-30
• 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, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Subjects with primary humoral immunodeficiency, namely with a diagnosis of
Common variable immunodeficiency (CVID) as defined by the Pan-American Group
for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies
(ESID) or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID or
autosomal recessive agammaglobulinemia who have participated in the study
ZLB06_001CR and who have tolerated IgPro20 well
• 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:
• Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as
total urine protein concentration > 0.2g/L)
• Other significant medical conditions that could increase the risk to the subject
• Females who are pregnant, breast feeding or planning a pregnancy during the
course of the study
• Participation in a study with an investigational medicinal product within three
months prior to enrollment, except for ZLB06_001CR
• Evidence of uncooperative attitude
• Any condition that is likely to interfere with evaluation of the IMP or satisfactory
conduct of the study
• Subjects 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: normal human immunoglobulin G
Concentration unit: % percent
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): • Descriptive comparison of serum IgG levels at visit 1, 3, 5, 7, 9, and 11

Main Objective: The objective of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with PID. In addition, long-term health-related quality of life (HRQL) will be assessed.

Secondary Objective:

Secondary ID(s)

2008-000830-30-DE

ZLB07_002CR