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

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 25

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): IgG Trough Level ;Timepoint(s) of evaluation of this end point: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of Infection Episodes (Serious and Non-serious) by Study Period <br>- Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population <br>- Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population <br>- Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period <br>- Number of Days of Hospitalization Due to Infections by Study Period <br>- Duration of Use of Antibiotics for Infection Prophylaxis and Treatment <br>- Rate of All Adverse Events by Relatedness and Seriousness <br>- Rate of Mild, Moderate, or Severe Local Reactions <br>- Annualized Rate of Serious Bacterial Infections (SBIs), PPS and FAS Population (Other pre-specified endpoint);Timepoint(s) of evaluation of this end point: Up to 36 weeks

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