Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-01 @ 11:56 PM
Study NCT ID:
NCT04309669
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Time required for a mean increase of at least 0,5g/dL from baseline in the haemoglobin level in patients with moderate IDA and daily treated with Tot'héma.", 'timeFrame': '12 weeks', 'description': 'Identification of the first time (in days) associated with a mean increase in the haemoglobin level of at least 0.5 g/dL (versus mean haemoglobin level at D0).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '41277915', 'type': 'DERIVED', 'citation': 'Cacoub P, Otieno FO, Trichereau J, Gobert O, Kerveillant AL, Escola J, Verriere F. Early Haematologic Response to Oral Iron Treatment in Adults With Moderate Iron-Deficiency Anaemia. Anemia. 2025 Nov 20;2025:8866390. doi: 10.1155/anem/8866390. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'Héma®. The onset of action is defined as the time required for a mean increase of at least 0,5g/dL from baseline in the haemoglobin level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult men and women (\\>18 years)\n2. Patient with a confirmation of moderate anemia defined as: 8 g/dL ≤ Haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before inclusion visit.\n3. Patient with ferritin blood level \\< lower limit of laboratory standard for this biological parameter at on the last hematological test performed within 7 days before inclusion visit.\n4. Patient who has read, understood, dated and signed the informed consent form\n\n6\\. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates\n\nNon-inclusion Criteria:\n\n1. Patient for whose an oral iron supplementation is not indicated or not recommended according to PI's opinion\n2. CRP \\> 10 mg/L on the last hematological test performed within 7 days before inclusion visit.\n3. Patient with benign or malignant neoplastic tumour\n4. Patient presenting gastrointestinal disorders incompatible with study treatment compliance\n5. Pregnant or breastfeeding woman\n6. Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception - per investigator's judgment\n7. Patient with surgery scheduled to occur during the treatment period\n8. Patient allergic or hypersensitive to any of the components of Tot'Héma® ampoule\n9. Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism\n10. Patient with active digestive bleeding (such as digestive ulcer)\n11. Patient having taken iron supplementation, iron-based IV therapy or mineral supplementation with iron, within the 15 days prior to the inclusion visit (V2)\n12. Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency\n13. Patient with acute malaria crisis within 15 days prior to inclusion\n14. Patient with a positive Faecal Occult Blood Test (FOBT)\n15. Patient with HIV infection\n16. Unreliable patients, including non-observant patients, patients with known alcoholism or drug abuse, or with a history of a serious psychiatric disorder, as well as patients who are reluctant to give informed consent or to comply with protocol requirement.\n\nSelection criterion 1. Patient with moderate anaemia defined as 8 g/dL ≤ haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before screening visit\n\nInclusion criteria\n\n1\\. Adult men and women (≥18 years) 2. Patient with a confirmation of moderate anaemia defined as 8 g/dL ≤ haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before inclusion visit 3. Patient with ferritin blood level \\< lower limit of laboratory standard for this biological parameter on the last hematological test performed within 7 days before inclusion visit 4. Patient who has read, understood, dated and signed the informed consent form 5. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates Non-inclusion criteria\n\n1. Patient for whom an oral iron supplementation is not indicated or not recommended according to Investigator's opinion\n2. C-Reactive Protein \\> 10 mg/L on the last hematological test performed within 7 days before inclusion visit\n3. Patient with benign or malignant neoplastic tumour\n4. Patient presenting gastrointestinal disorders incompatible with study treatment compliance\n5. Pregnant or breastfeeding woman\n6. Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception - per investigator's judgment\n7. Patient with surgery scheduled to occur during the treatment period\n8. Patient allergic or hypersensitive to any of the components of Tot'héma® ampoule\n9. Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism\n10. Patient with active digestive bleeding (such as digestive ulcer)\n11. Patient having taken iron supplementation, iron-based IV therapy mineral supplementation with iron within the 15 days prior to the inclusion visit (V2)\n12. Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency\n13. Patient with acute malaria crisis within 15 days prior to inclusion\n14. Patient with a positive Faecal Occult Blood Test (FOBT)\n15. Patient with HIV infection\n16. Unreliable patients, including non-observant patients, patients with known alcoholism or drug abuse, or with a history of a serious psychiatric disorder, as well as patients who are reluctant to give informed consent or to comply with protocol requirement.\n17. Patient with a family relationship to a person at the investigator's site or at the Sponsor or at the CRO.\n18. Participant involved in another interventional or observational clinical trial or who participated in another interventional clinical trial within four weeks before inclusion."}, 'identificationModule': {'nctId': 'NCT04309669', 'acronym': 'FAST', 'briefTitle': "Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia", 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Innotech International'}, 'officialTitle': "Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia", 'orgStudyIdInfo': {'id': 'TOT401-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Tot'hema", 'description': 'three ampoules per day during 12 weeks daily dose: 150mg of iron per day.', 'interventionNames': ["Drug: TOT'HEMA"]}], 'interventions': [{'name': "TOT'HEMA", 'type': 'DRUG', 'description': 'three ampoules per day during 12 weeks', 'armGroupLabels': ["Tot'hema"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Innotech International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}