Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-04-12 @ 7:56 AM
Study NCT ID:
NCT01766934
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.", 'timeFrame': 'each patient will be followed for 10 years after mobilization', 'description': "The primary objective is to investigate adverse events that are suspected to be related to stem cell mobilization with the Sandoz' filgrastim in healthy unrelated donors."}], 'secondaryOutcomes': [{'measure': 'Efficacy assessment in terms of the CD34+ cell count.', 'timeFrame': 'CD34+ cells are counted on 1 day immediately preceding apheresis', 'description': "The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral blood progenitor cell mobilization', 'allogenic hematopoetic stem cell transplantation', 'recombinant human granulocyte colony stimulating factor', 'filgrastim'], 'conditions': ['Hematopoietic Stem Cell Mobilization']}, 'referencesModule': {'references': [{'pmid': '35287672', 'type': 'DERIVED', 'citation': 'Heyn J, Brauninger S, Dimova-Dobreva M, Mathieson N, Koptelova N, Kolpakova A, Seidl C, Reinhardt P, Tsamadou C, Schrezenmeier H, Nakov R, Seifried E, Bonig H. Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation. J Transl Med. 2022 Mar 14;20(1):121. doi: 10.1186/s12967-022-03322-w.'}]}, 'descriptionModule': {'briefSummary': 'Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.', 'detailedDescription': "This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nVolunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization\n\nExclusion Criteria:\n\n* Donors of age \\<18 years\n* Related to recipient\n* Chronic significant organ diseases\n* Systemic autoimmune diseases\n* Chronic infectious diseases\n* History of malignant disease\n* Pregnant and breastfeeding women\n* Hypersensitivity to E. coli derived proteins\n* Hypersensitivity to the active substance or to any of the excipients of Sandoz' filgrastim\n* Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim\n* Participation in previous stem cell mobilization procedures\n* Previous or concurrent use of other mobilizing agents, e.g. plerixafor\n* Informed consent was not signed prior to beginning of documentation."}, 'identificationModule': {'nctId': 'NCT01766934', 'acronym': 'SMART', 'briefTitle': 'Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization', 'orgStudyIdInfo': {'id': 'EP06-501'}}, 'contactsLocationsModule': {'locations': [{'zip': '60528', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Hexal AG', 'role': 'STUDY_CHAIR', 'affiliation': 'Hexal AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hexal AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}