Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

CSL Behring

Status and phase: Completed; Phase 3

Conditions: X-linked Agammaglobulinemia; Autosomal Recessive Agammaglobulinemia; Common Variable Immunodeficiency

Treatments: Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542997

ZLB06_001CR (Other Identifier)

1460

Details and patient eligibility

About

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Full description

This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).

Enrollment: 51 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 European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
• Chest X-ray or CT scan obtained within 1 year prior to enrolment

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
• Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA

Additional criteria may apply and examination by an investigator is required to determine eligibility.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

IgPro20

Experimental group

Treatment:

Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)