Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-30 @ 8:44 PM
Study NCT ID:
NCT05795361
Status:
AVAILABLE
Last Update Posted:
2025-04-22
First Post:
2023-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016532', 'term': 'Mucopolysaccharidosis II'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D009083', 'term': 'Mucopolysaccharidoses'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Hunter Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/1a50b2ee12ee4e80?idFilter=%5B%22TAK-609-5005%22%5D', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program.\n2. Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment).\n\nExclusion Criteria:\n\n1. Participant has a condition that in the opinion of the treating physician may compromise their safety.\n2. Participant has a known hypersensitivity to idursulfase-IT or its components.'}, 'identificationModule': {'nctId': 'NCT05795361', 'briefTitle': 'Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment', 'orgStudyIdInfo': {'id': 'TAK-609-5005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Idursulfase-IT', 'type': 'DRUG', 'otherNames': ['HGT-2310', 'TAK-609'], 'description': 'Participants will continue to receive the same dose of idursulfase-IT, once monthly, that was administered during the HGT-HIT-046 \\[NCT01506141\\] or SHP609-302 \\[NCT02412787\\] study \\[10mg or 30mg\\] along with intravenous (IV) infusions of standard-of-care therapy Elaprase via intrathecal drug delivery device (IDDD) or lumbar punctures.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'jknoll@phoenixchildrens.com'}, {'name': 'Jasmine Knoll', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'paul.harmatz@ucsf.edu'}, {'name': 'Paul Harmatz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Regents of the University of California', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'jeffrey.campbell@nemours.org'}, {'name': 'Jeffery Campbell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Nemours Foundation', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'wthorson@med.miami.edu'}, {'name': 'Willa Thorson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jackson Memorial Hospital University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'bburton@luriechildrens.org'}, {'name': 'Barbara Burton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ann and Robert H Lurie Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63130', 'city': 'Washington', 'state': 'Missouri', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'grangedk@wustl.edu'}, {'name': 'Dorothy Grange', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '68198-5450', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'wrizzo@unmc.edu'}, {'name': 'William Rizzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Board of Regents of the University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'helio.pedro@hmhn.org'}, {'name': 'Helio Pedro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Joseph M. Sanzari Children's Hospital", 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'devorah.segal@nyulangone.org'}, {'name': 'Devorah Segal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'muenzer@med.unc.edu'}, {'name': 'Joesph Muenzer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'hannar2@ccf.org'}, {'name': 'Rabi Hanna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'ganadiot@lhs.org'}, {'name': 'George Anadiotis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Randall Children's Hospital at Legacy Emanuel", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'ficicioglu@chop.edu'}, {'name': 'Can Ficicioglu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'damara.ortiz@chp.edu'}, {'name': 'Damara Ortiz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UPMC Childrens Hospital of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232-7610', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'neena.agrawal@vumc.org'}, {'name': 'Neena Agrawal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Vanderbilt Children's Hospital", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'dave.viskochil@hsc.utah.edu'}, {'name': 'David Viskochil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Medical Genetics, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'angela.sun@seattlechildrens.org'}, {'name': 'Emily Shelkowitz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital - PIN", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'QLD 4101', 'city': 'South Brisbane', 'state': 'Queensland', 'status': 'AVAILABLE', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'anita.inwood@health.qld.gov.au'}, {'name': 'Anita Inwood', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queensland Childrens Hospital', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4530', 'city': 'Coyoacán', 'state': 'Mexico City', 'status': 'AVAILABLE', 'country': 'Mexico', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'maatilderuizg@gmail.com'}, {'name': 'Matilde Ruiz-Garcia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Nacional de Pediatria', 'geoPoint': {'lat': 19.3467, 'lon': -99.16174}}, {'zip': '47003', 'city': 'Valladolid', 'status': 'AVAILABLE', 'country': 'Mexico', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'mcastrorey@saludcastillayleon.es'}, {'name': 'Margarita Castro Rey', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H.C.U. de Valladolid', 'geoPoint': {'lat': 20.68812, 'lon': -88.19936}}, {'zip': '14004', 'city': 'Córdoba', 'status': 'AVAILABLE', 'country': 'Spain', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'mercedes_gil_campos@yahoo.es'}, {'name': 'Mercedes Gil Campos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'status': 'AVAILABLE', 'country': 'United Kingdom', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'Simon.Jones@mft.nhs.uk'}, {'name': 'Simon Jones', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Royal Manchester Children's Hospital - PPDS", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Takeda Contact', 'role': 'CONTACT', 'email': 'medinfoUS@takeda.com', 'phone': '+1877-825-3327'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}