Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-25 @ 12:33 PM
Study NCT ID:
NCT00144495
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2005-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The increase in Hb concentration', 'timeFrame': 'Day 28th or later'}], 'secondaryOutcomes': [{'measure': 'Changes in QOL scores', 'timeFrame': '84 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy Induced Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients\n\nExclusion Criteria:\n\n* a history of myocardial, cerebral or pulmonary infarction\n* severe hypertension beyond control by drugs'}, 'identificationModule': {'nctId': 'NCT00144495', 'briefTitle': 'A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy', 'orgStudyIdInfo': {'id': 'EPO308JP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patient whose ΔHb is less than 1.0g/dL on the day of 7th administration', 'interventionNames': ['Drug: recombinant human erythropoietin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'patient whose ΔHb is 1.0g/dL or above on the day of 7th administration', 'interventionNames': ['Drug: recombinant human erythropoietin']}], 'interventions': [{'name': 'recombinant human erythropoietin', 'type': 'DRUG', 'description': '3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks', 'armGroupLabels': ['1']}, {'name': 'recombinant human erythropoietin', 'type': 'DRUG', 'description': '36000IU(s.c.)/week for 12 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yoshiharu Ishikura', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chugai Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical', 'oldOrganization': 'Chugai Pharmaceutical'}}}}