Phase 3
Completed N=51
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Common Variable Immunodeficiency · X-linked Agammaglobulinemia · Autosomal Recessive Agammaglobulinemia
Source: ClinicalTrials.gov NCT00542997 ↗
Enrolled (actual)
51
Serious AEs
9.8%
Results posted
Mar 2011
Primary outcomePrimary: Total Serum IgG Trough Levels — 8.10; 7.49 g/L
Summary
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Serum IgG Trough Levels |
8.10; 7.49 | — |
| SECONDARY Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population) |
— | — |
| SECONDARY Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population) |
— | — |
| SECONDARY Annual Rate of Infection Episodes |
5.18 | — |
| SECONDARY Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections |
8.00 | — |
| SECONDARY Annual Rate of the Number of Days of Hospitalization Due to Infections |
3.48 | — |
| SECONDARY Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment |
72.75 | — |
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 European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
- Chest X-ray or CT scan obtained within 1 year prior to enrolment
Exclusion Criteria
- Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
- 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
- Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
Additional criteria may apply and examination by an investigator is required to determine eligibility.
Data sourced from ClinicalTrials.gov (NCT00542997). 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.