Phase 3
N=40
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Primary Immunodeficiency (PID)
Bottom Line
View on ClinicalTrials.gov: NCT00751621 ↗Enrolled (actual)
40
Serious AEs
35.0%
Results posted
Jan 2013
Primary outcome: Primary: Total Serum IgG Trough Levels — 7.97 g/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IgPro20 (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Serum IgG Trough Levels |
7.97 | — |
| SECONDARY Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) |
0.048; 0.1252 | — |
| SECONDARY Annualized Rate of Infection Episodes |
3.334 | — |
| SECONDARY Number of Infection Episodes |
349 | — |
| SECONDARY Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections |
6.773 | — |
| SECONDARY Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections |
706 | — |
| SECONDARY Annualized Rate of Hospitalization Due to Infections |
1.055 | — |
| SECONDARY Number of Days of Hospitalization Due to Infections |
110 | — |
| SECONDARY Use of Antibiotics for Infection Prophylaxis and Treatment |
72.13 | — |
| SECONDARY Health Related Quality of Life (Short Form 36 Health Survey) |
95.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit. |
— | — |
| SECONDARY Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit. |
3; 1; 0 | — |
| SECONDARY Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion |
0.0936; 0.0685; 0.0231; 0.0020; 0.0026; 0.0033 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00751621). 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.