Phase 3
Completed N=23
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Primary Immune Deficiency Disorder
Source: ClinicalTrials.gov NCT01458171 ↗
Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Apr 2013
Primary outcomePrimary: Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion — 0.167; 0.125; 0; 0 AEs per infusion
Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06\_002CR (NCT01199705).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion |
0.167; 0.125; 0; 0; 0.125; 0 | — |
| SECONDARY Overall Rate of AEs Per Infusion |
0.346; 0.342; 0.002; 0.002; 0.210; 0.136 | — |
| SECONDARY Number of Subjects With Newly Developing or Worsening AEs |
22; 21; 1; 1; 12; 10 | — |
| SECONDARY Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good' |
85.4 | — |
| SECONDARY IgG Trough Level |
7.469; 7.586; 8.914; 8.227; 1.445; 0.642 | — |
| SECONDARY Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) |
0.00; 0.00 | — |
| SECONDARY Number of Infection Episodes (Serious and Non-serious) |
43; 38 | — |
| SECONDARY Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections. |
0; 0 | — |
| SECONDARY Number of Days of Hospitalization Due to Infections. |
0; 0 | — |
| SECONDARY Duration of Use of Antibiotics for Infection Prophylaxis and Treatment |
91.5; 154.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have participated in study ZLB06\_002CR and who have tolerated IgPro20 well.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.
Exclusion Criteria
- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06\_002CR.
- Subjects who are planning to donate blood during the study.
- Re-entry of subjects previously participating in the current follow-up study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
Data sourced from ClinicalTrials.gov (NCT01458171). 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. Informational only — not medical advice.