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

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Primary Immune Deficiency

Treatments: Biological: Immune Globulin Subcutaneous (Human) (SCIG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199705

U1111-1116-6379 (Other Identifier)

ZLB06_002CR

Details and patient eligibility

About

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Enrollment: 25 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
• Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
• Written informed consent

Exclusion criteria

• Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
• Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
• Ongoing or history of concomitant 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 recorded in the past 3 months or at the time of screening
• Pregnancy or nursing mother
• A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
• Participation in a study with other investigational product during this study and within 3 months prior to screening
• Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

IgPro20

Experimental group

Treatment:

Biological: Immune Globulin Subcutaneous (Human) (SCIG)