Phase 3
Completed N=21
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Primary Immune Deficiency
Source: ClinicalTrials.gov NCT00719680 ↗
Enrolled (actual)
21
Serious AEs
19.1%
Results posted
Jan 2013
Primary outcomePrimary: Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) — 0.06 infections per subject year
Summary
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) |
0.06 | — |
| PRIMARY Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population) |
0.03 | — |
| SECONDARY Annualized Rate of Any Infection |
2.38 | — |
| SECONDARY Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations |
11.98 | — |
| SECONDARY Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection |
6.67 | — |
| SECONDARY Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection |
4.28 | — |
| SECONDARY Number of Days of Hospitalization Due to Infection |
0.857 | — |
| SECONDARY Annualized Rate of Hospitalization Due to Infection |
0.55 | — |
| SECONDARY Use of Antibiotics for Infection Prophylaxis and Treatment |
83.87 | — |
| SECONDARY Rate of All AEs by Relatedness and Severity |
0.661; 0.137; 0.524; 0.575; 0.076; 0.010 | — |
| SECONDARY Relatedness and Severity of All AEs (Percentage of Total AEs) |
20.7; 79.3; 87.0; 11.5; 1.5 | — |
| SECONDARY Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion |
21; 21 | — |
| SECONDARY Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion |
0.322; 0.575 | — |
| SECONDARY Number of Subjects Reporting Mild, Moderate, or Severe Local AEs |
19; 16; 3; 0 | — |
| SECONDARY Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs |
— | — |
| SECONDARY Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters |
— | — |
| SECONDARY Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with primary humoral immunodeficiency who have participated in the study ZLB04\_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
- Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
- Written informed consent
Exclusion Criteria
- Ongoing serious bacterial infection at the time of screening
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
- Other significant medical conditions that could increase the risk to the patient
- Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
- A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04\_009CR (NCT00419341)
- Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04\_009CR (NCT00419341)
- Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
- Evidence of uncooperative attitude
- Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
- Subjects who are employees at the investigational site, relatives or spouse of the investigator
Data sourced from ClinicalTrials.gov (NCT00719680). 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.