Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Primary Immunodeficiency (PID)

Treatments: Biological: IgPro20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751621

ZLB07_002CR

2008-000830-30 (EudraCT Number)

1472 (Other Identifier)

Details and patient eligibility

About

This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.

Enrollment: 40 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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 IgPro well
• Written informed consent

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

IgPro20

Experimental group

Description:

Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).

Treatment:

Biological: IgPro20