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

NCT ID: NCT00546871

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-03
• Study Completion Date: 2009-09-01

Brief 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.

Conditions

Primary Immunodeficiency Diseases (PID)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Immune Globulin Intravenous (Human), 10%

Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Los Angeles, California, United States

Centennial, Colorado, United States

North Palm Beach, Florida, United States

Atlanta, Georgia, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Dallas, Texas, United States

Galveston, Texas, United States

Milwaukee, Wisconsin, United States

Countries

United States

References

Neu AM, Warady BA, Furth SL, Lederman HM, Fivush BA. Antibody levels to diphtheria, tetanus, and rubella in infants vaccinated while on PD: a Study of the Pediatric Peritoneal Dialysis Study Consortium. Adv Perit Dial. 1997;13:297-9.

Reference Type: BACKGROUND

PMID: 9440877 (View on PubMed)

Leibl H, Engl W, Melamed I, Stein M, Wasserman RL, Berger M, Schiff RI. IGIV-10% Infused Intravenously And Subcutaneously To Subjects With Primary Immunodeficiency Diseases - Comparison Of Pharmacokinetic Properties. Poster presentation at AAAAI 2009.

Reference Type: RESULT

Schiff RI, Leibl H, Engl W. Pharmacokinetic properties of Gammagard Liquid 10% (KIOVIG) administered intravenously and subcutaneously to patients with primary immunodeficiency diseases. Clin Exp Immunol. 154 (Suppl. 1):132, 2008

Reference Type: RESULT

Wasserman RL, Melamed I, Kobrynski L, Strausbaugh SD, Stein MR, Sharkhawy M, Engl W, Leibl H, Sobolevsky L, Gelmont D, Schiff RI, Grossman WJ. Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011 Jun;31(3):323-31. doi: 10.1007/s10875-011-9512-z. Epub 2011 Mar 22.

Reference Type: RESULT

PMID: 21424824 (View on PubMed)

Wasserman RL, Gupta S, Stein M, Rabbat CJ, Engl W, Leibl H, Yel L. Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases. Immunotherapy. 2022 Mar;14(4):215-224. doi: 10.2217/imt-2021-0256. Epub 2021 Dec 21.

Reference Type: DERIVED

PMID: 34931880 (View on PubMed)

Other Identifiers

160601

Identifier Type: -

Identifier Source: org_study_id