Phase 3
N=25
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Primary Immune Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01199705 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Mar 2013
Primary outcome: Primary: IgG Trough Level — 1.09; 1.11 Ratio of Geometric Means
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Immune Globulin Subcutaneous (Human) (SCIG) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IgG Trough Level |
1.09; 1.11 | — |
| SECONDARY Number of Infection Episodes (Serious and Non-serious) by Study Period |
19; 22; 28; 32; 15; 18 | — |
| SECONDARY Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population |
5.74; 5.79; 2.98 | — |
| SECONDARY Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population |
5.75; 5.79; 3.14 | — |
| SECONDARY Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Days of Hospitalization Due to Infections by Study Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Use of Antibiotics for Infection Prophylaxis and Treatment |
48.5; 48.0; 49.0; 35.5; 71.0; 71.0 | — |
| SECONDARY Rate of All Adverse Events by Relatedness and Seriousness |
0.653; 0.457; 0.027; 0.296; 0; 0.002 | — |
| SECONDARY Rate of Mild, Moderate, or Severe Local Reactions |
0; 0.274; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01199705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.