Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 5:40 AM
Study NCT ID:
NCT01844635
Status:
UNKNOWN
Last Update Posted:
2016-04-01
First Post:
2013-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C512542', 'term': 'thymoglobulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.', 'timeFrame': 'day 180 after the start of IST'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acquired Aplastic Anemia.']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acquired aplastic anemia\n* Age: younger than 70 years old\n* Severity: SAA, VSAA.\n* Interval between diagnosis and registration \\<6 months.\n* Written informed consent from the caretakers and/or whenever possible consent from the patient.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01844635', 'briefTitle': 'Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA', 'organization': {'class': 'OTHER', 'fullName': 'Nagoya University'}, 'officialTitle': 'A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia', 'orgStudyIdInfo': {'id': 'APBMT AAWG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2.5 mg/kg/day of Thymoglobulin for 5 days', 'description': '2.5 mg/kg/day of Thymoglobulin for 5 days', 'interventionNames': ['Drug: Thymoglobulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3.5 mg/kg/day of Thymoglobulin for 5 days', 'description': '3.5 mg/kg/day of Thymoglobulin for 5 days', 'interventionNames': ['Drug: Thymoglobulin']}], 'interventions': [{'name': 'Thymoglobulin', 'type': 'DRUG', 'armGroupLabels': ['2.5 mg/kg/day of Thymoglobulin for 5 days', '3.5 mg/kg/day of Thymoglobulin for 5 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8550', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Seiji Kojima, MD., PhD.', 'role': 'CONTACT', 'email': 'kojimas@med.nagoya-u.ac.jp', 'phone': '+81-52-744-2294'}, {'name': 'Hideki Muramatsu, MD., PhD.', 'role': 'CONTACT', 'email': 'hideki-muramatsu@med.nagoya-u.ac.jp', 'phone': '+81-52-744-2294'}, {'name': 'Seiji Kojima, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Pediatrics, Nagoya University Graduate School of Medicine', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}], 'centralContacts': [{'name': 'Seiji Kojima, MD., PhD.', 'role': 'CONTACT', 'email': 'kojimas@med.nagoya-u.ac.jp', 'phone': '+81-52-744-2294'}, {'name': 'Hideki Muramatsu, MD., PhD.', 'role': 'CONTACT', 'email': 'hideki-muramatsu@med.nagoya-u.ac.jp', 'phone': '+81-52-744^2294'}], 'overallOfficials': [{'name': 'Seiji Kojima, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Nagoya University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagoya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hideki Muramatsu', 'investigatorAffiliation': 'Nagoya University'}}}}