Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT00161993
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D000361', 'term': 'Agammaglobulinemia'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D012997', 'term': 'Solvents'}, {'id': 'D003902', 'term': 'Detergents'}], 'ancestors': [{'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2003-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-22', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)', 'timeFrame': '21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit'}]}, 'conditionsModule': {'keywords': ['Gammaglobulin'], 'conditions': ['Primary Immunodeficiency Diseases (PID)', 'Agammaglobulinemia', 'Hypogammaglobulinemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects will be eligible for study entry if they:\n\n* are at least 18 years old\n* have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy\n* have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously\n* have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening\n* if female of childbearing potential, agree to employ adequate birth control measures during the study\n* have given written informed consent\n\nExclusion Criteria:\n\nSubjects will not be eligible for study entry if they:\n\n* had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study\n* suffer from documented selective IgA deficiency with antibodies against IgA\n* have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)\n* are known to be infected with HIV, HCV, or HBV\n* are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style\n* suffer from congestive heart failure and receive on-demand treatment with furosemide\n* show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit\n* received another investigational drug in the three weeks preceding study entry\n* in case of females, are pregnant or nursing mothers'}, 'identificationModule': {'nctId': 'NCT00161993', 'briefTitle': 'Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia', 'orgStudyIdInfo': {'id': '160001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution', 'type': 'DRUG'}, {'name': 'Gammagard S/D (Solvent/Detergent)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33 521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '205 20', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'SU/Sahlgrenska', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'University Hospital Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'University Hospital MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '851 86', 'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Sundsvall Hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}