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Immune Globulin Subcutaenous (Human), 20%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01412385
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

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

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : June 20, 2011
Actual Primary Completion Date : May 13, 2014
Actual Study Completion Date : May 13, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Names:
  • IGSC
  • 20%

Biological: Immune Globulin Intravenous (Human), 10%
Intravenous infusion (regulated via a pump)
Other Names:
  • GAMMAGARD LIQUID (tradename in the US and Canada)
  • KIOVIG (trademark in Europe)
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 Names:
  • IGSC
  • 20%

Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)
Subcutaneous infusion (regulated via a pump)
Other Name: SUBCUVIA


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412385


Locations
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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
Baxalta now part of Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01412385    
Other Study ID Numbers: 170903
2010-019459-23 ( EudraCT Number )
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn
Immunoglobulins
Immunoglobulins, Intravenous
 Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs