Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration

• Diagnosis of a PID disorder as defined by World Health Organization criteria (IUIS Scientific Committee, Primary immunodeficiency diseases. Report of an IUIS Scientific Committee. Clin Exp Immunol. 1999) for which the subject has been receiving a regular regimen of IV immunoglobulin infusions every 21 ± 3 days or 28 ± 3 days or a regular SC immunoglobulin treatment at 1 to 2 week intervals over a period of at least 3 months pre-study at a dose of 300-800 mg/kg BW/4 weeks

• Subjects are aged 2 years or older

• Subjects have a serum trough level of IgG > 4.5 g/L at the last documented determination

• A negative serum pregnancy test for any female subject who is of childbearing potential

• Female subjects of childbearing potential agree to practice birth control measures for the duration of the study

Exclusion Criteria:

• Subjects positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), PCR for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1

• Subjects with levels of alanine amino transferase (ALT) or aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory

• Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3)

• Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender

• Subjects with a malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)

• Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)

• Subjects with anemia that would preclude phlebotomy for laboratory studies

• Subjects who received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to study enrollment

• Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin and/or ISG infusions

• Subjects with IgA deficiency and known anti IgA antibodies

• Subjects receiving antibiotic therapy for the treatment of infection within 7 days prior to enrollment

• Subjects participating in another clinical study involving an investigational product or device within 28 days prior to study enrollment

• Subjects with bleeding disorders or who are on anti-coagulation therapy