Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 7:27 AM
Study NCT ID:
NCT04237233
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2019-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intense Monitoring Study on Tyvyt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2019-12-31', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of known adverse drug reactions', 'timeFrame': 'During the actual Tyvyt treatment time.'}, {'measure': 'Occurrence of new adverse drug reactions', 'timeFrame': 'During the actual Tyvyt treatment time.'}, {'measure': 'Association, risk factors, severity and incidence of immune-related adverse drug reactions/events', 'timeFrame': 'During the actual Tyvyt treatment time.'}, {'measure': 'Association, risk factors, severity and incidence of serious adverse drug reactions', 'timeFrame': 'During the actual Tyvyt treatment time.'}, {'measure': 'Occurrence of adverse drug reactions in special population', 'timeFrame': 'During the actual Tyvyt treatment time.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'During the actual Tyvyt treatment time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Relapsed or Refractory Classical Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The main study population is target indication patients treated with Tyvyt® within the territory of China. If any new indication is approved during the implementation of the project, and there are no special requirements for the approval, the new indication patients using Tyvyt® will also be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must be able to understand and voluntarily sign the informed consent form (ICF).\n\nPatients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.\n\nPatients must have agreed to use Tyvyt® to treat the target indication.\n\nExclusion Criteria:\n\nPatients refuse to be included in the study or refuse to cooperate.\n\nPatients have participated in another interventional studies within 4 weeks prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT04237233', 'briefTitle': 'Intense Monitoring Study on Tyvyt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'Intense Monitoring Study on Sintilimab Injection (Tyvyt®)', 'orgStudyIdInfo': {'id': 'CIBI308B401'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Zhao', 'role': 'CONTACT', 'email': 'lei.zhao01@innoventbio.com', 'phone': '+86 021 31837200'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}