Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT03055559
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2017-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Protocol GlobiFer - Oral Iron Repletion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron, Hemoglobin, Feritin, erytrocyty. transferin'], 'conditions': ['Iron Deficiency']}, 'descriptionModule': {'briefSummary': 'The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female , ≥ 18 ≤ 60 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥ 18 ≤ 60 years of age\n2. Signed written informed consent\n3. Hb ≥ 8 ≤ 10g/dl for\n4. Female\n\nExclusion Criteria:\n\n1. History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).\n2. Known hypersensitivity to oral iron preparations.\n3. Diseases, which an iron supplementation is not allowed or contraindicated.\n4. Patients on current oral or intravenous iron supplementation\n5. History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.\n6. Patients who have had iron supplementation within the last 30 days.\n7. Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.\n8. Inability to comprehend study protocol\n9. Participation in another clinical trial (currently or within the last 30 days)"}, 'identificationModule': {'nctId': 'NCT03055559', 'acronym': 'TPG', 'briefTitle': 'Trial Protocol GlobiFer - Oral Iron Repletion', 'organization': {'class': 'OTHER', 'fullName': 'Gedeon Richter Slovakia, s.r.o.'}, 'officialTitle': 'Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment', 'orgStudyIdInfo': {'id': 'Not identified'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Globifer Forte', 'interventionNames': ['Dietary Supplement: Globifer Forte']}], 'interventions': [{'name': 'Globifer Forte', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Globifer Forte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '036 01', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Prof. MUDr. Ján Danko, PhD.', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Ján Danko, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Comenius University's Jessenius Faculty of Medicine"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gedeon Richter Slovakia, s.r.o.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}