Immune Globulin Subcutaenous (Human), 20%

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01412385
First received: August 8, 2011
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.


Condition Intervention Phase
Primary Immunodeficiency Diseases (PID)
Biological: Immune Globulin Subcutaneous (Human), 20%
Biological: Immune Globulin Intravenous (Human), 10%
Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Acute serious bacterial infection rate defined as the mean number of acute serious bacterial infections per subject per year in the intent-to-treat population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections


Enrollment: 55
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoch 1 (intravenous pre-study treatment) + Epoch 2
Study Epoch 1 (13 weeks): treatment with KIOVIG (once every 3 or 4 weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents)
Biological: Immune Globulin Subcutaneous (Human), 20%
Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)
Other Name: IGSC, 20%
Biological: Immune Globulin Intravenous (Human), 10%
Intravenous infusion (regulated via a pump)
Other Names:
  • KIOVIG (trademark in Europe)
  • GAMMAGARD LIQUID (tradename in the US and Canada)
Experimental: Epoch 1 (subcutaneous pre-study treatment) + Epoch 2
Study Epoch 1 (12 weeks): treatment with SUBCUVIA (once every week or once every two weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents)
Biological: Immune Globulin Subcutaneous (Human), 20%
Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)
Other Name: IGSC, 20%
Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)
Subcutaneous infusion (regulated via a pump)
Other Name: SUBCUVIA

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin replacement, as defined according to the IUIS Scientific Committee 2009, and by diagnostic criteria according to Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Clin Immunol 1999; 93:190-197. The diagnosis must be confirmed by the Medical Director prior to enrollment.
  • Subject is 2 years or older at the time of screening
  • Written informed consent is obtained from either the subject or the subject's legally authorized representative prior to any study-related procedures and study product administration
  • Subject has been receiving a consistent dose of IgG over a period of at least 3 months prior to screening at an average minimum dose over that interval equivalent to 300 mg/kg body weight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks at a dosing frequency as follows:

    1. intravenously (IV) at mean intervals of approximately 3 or 4 weeks or
    2. subcutaneously (SC) at mean intervals of approximately 1 or 2 weeks
  • Subject has a serum trough level of IgG > 5 g/L at screening
  • Subject has not had a serious bacterial infection within the 3 months prior to screening
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
  • Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):

    1. Persistent alanine aminotransferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
    2. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] <= 500 /mm3)
  • Subject has creatinine clearance (CLcr) value that is < 60% of normal for age and gender
  • Subject has been diagnosed with or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
  • Subject is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening or a history of thrombophilia
  • Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
  • Subject has anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
  • Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
  • Subject has immunoglobulin A (IgA) deficiency (IgA less than 0.07g/L) and known anti IgA antibodies
  • Subject is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening
  • Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
  • Subject has a bleeding disorder or a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
  • Subject has total protein >9 g/dL or myeloma, or macroglobulinemia (IgM) or paraproteinemia
  • Women of childbearing potential meeting any one of the following criteria

    1. subject presents with a positive pregnancy test
    2. subject is breast feeding
    3. subject intends to begin nursing during the course of the study
    4. subject does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
  • Subject has participated in another clinical study and has been exposed to an investigational product (IP) or device within 30 days prior to study enrollment (exception: treatment with immunoglobulin pre-study)
  • Subject is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an IP or device during the course of the study
  • Subject has severe dermatitis that would preclude adequate sites for safe product administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412385

Locations
Austria
Medizinische Universität Wien / AHK Wien (General Hospital Vienna), Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria, 1090
Germany
Universitätsklinikum Erlangen, Medizinische Klinik 3
Erlangen, Germany, 91054
University Medical Centre Freiburg, Centre of Chronic Immunodeficiency, Divison of Rheumatology and Clinical Immunology
Freiburg, Germany, 79106
Universitätsklinikum Hamburg-Eppendorf, Kinderklinik
Hamburg, Germany, 20246
Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie
Hannover, Germany, 30625
Klinikum St. Georg GmbH, Klinik für Kinder- und Jugendmedizin
Leipzig, Germany, 04129
Hungary
Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház, Gyermekhematológiai és Őssejt-transzplantációs Osztály
Budapest, Hungary, 1097
University of Debrecen, Medical and Health Science Center, Department of Infectious and Pediatric Immunology
Debrecen, Hungary, 4012
Sweden
The Queen Silvia Children´s Hospital
Gothenburg, Sweden, 416 85
United Kingdom
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust, Immunology Department
Birmingham, United Kingdom, B9 5SS
Addenbrooke´s Hospital, Department of Clinical Immunology
Cambridge, United Kingdom, CB2 2QQ
Royal London Hospital, Barts and the London NHS Trust, Department of Immunology
London, United Kingdom, E1 2ES
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Leman Yel, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01412385     History of Changes
Other Study ID Numbers: 170903
Study First Received: August 8, 2011
Last Updated: April 4, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: Medicines Evaluation Board (MEB)
Hungary: National Institute of Pharmacy
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014