Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-02 @ 1:35 AM
Study NCT ID:
NCT06287268
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revolade Tablets Specified Drug-use Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520809', 'term': 'eltrombopag'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of serious adverse events', 'timeFrame': 'Up to 1 year', 'description': 'Occurrence of serious adverse events to be provided'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation', 'timeFrame': 'Up to 1 Year', 'description': 'Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation to be provided'}, {'measure': 'Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)', 'timeFrame': 'Up to 1 year', 'description': 'Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)'}, {'measure': 'Occurrence of clonal evolution', 'timeFrame': 'Up to 1 year', 'description': 'Occurrence of clonal evolution \\[cytogenetic abnormalities, myelodysplastic syndrome (MDS), Acute Myeloid Leukemia (AML), and paroxysmal nocturnal hemoglobinuria (PNH)\\]'}, {'measure': 'Hematologic response status', 'timeFrame': 'Up to 1 year', 'description': 'Hematologic response status to be provided'}, {'measure': 'Change over time from baseline in platelet count', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in platelet count to be provided'}, {'measure': 'Change over time from baseline in hemoglobin', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in hemoglobin to be provided'}, {'measure': 'Change over time from baseline in neutrophil count', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in neutrophil count to be provided'}, {'measure': 'Change over time from baseline in reticulocyte count', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in reticulocyte count to be provided'}, {'measure': 'Change over time from baseline in transfusion dependence', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in transfusion dependence to be provided'}, {'measure': 'Change over time from baseline in transfusion volume', 'timeFrame': 'Baseline, 1 year', 'description': 'Change over time from baseline in transfusion volume to be provided'}]}, 'conditionsModule': {'keywords': ['NIS', 'Pediatric Aplastic Anemia', 'AA', 'Revolade Tablets', 'eltrombopag', 'Drug-use Survey'], 'conditions': ['Aplastic Anemia']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).', 'detailedDescription': 'The objective of this survey is to confirm the safety and efficacy of eltrombopag in ATG treatment naive pediatric patients with AA. Eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. The observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. However, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The survey will be conducted in pediatric patients with Aplastic anemia (AA) who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA."', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey\n* Patients aged ≥ 6 years and \\< 18 years at the start of treatment with eltrombopag\n* Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA"\n\nExclusion Criteria:\n\n* Patients who have received ATG without concomitant use of eltrombopag\n* Patients with congenital AA\n* Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag\n* Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)'}, 'identificationModule': {'nctId': 'NCT06287268', 'briefTitle': 'Revolade Tablets Specified Drug-use Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)', 'orgStudyIdInfo': {'id': 'CETB115G1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eltrombopag', 'description': 'ATG treatment naïve pediatric patients with AA in routine clinical practice', 'interventionNames': ['Other: eltrombopag']}], 'interventions': [{'name': 'eltrombopag', 'type': 'OTHER', 'description': 'This is an observational study. There is no treatment allocation. After confirming that patients are fulfilling the eligibility criteria, patients will be registered in this survey.', 'armGroupLabels': ['eltrombopag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '453-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466 8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '470 1192', 'city': 'Toyoake', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'zip': '660 8550', 'city': 'Amagasaki', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '390-8621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '901-1303', 'city': 'Shimajiri-Gun', 'state': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '594-1101', 'city': 'Izumi', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.48333, 'lon': 135.43333}}, {'zip': '589 8511', 'city': 'Ōsaka-sayama', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}, {'zip': '520-2192', 'city': 'Ohtsu', 'state': 'Shiga', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '104 8560', 'city': 'Chuo Ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '143 8541', 'city': 'Ōta-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '534-0021', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '330 8777', 'city': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+81337978748'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}