Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02628860
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2015-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative transfusion rate', 'timeFrame': 'from preoperative baseline within the first 7 days after surgery', 'description': 'To evaluate reducing transfusion rate during perioperative period'}], 'secondaryOutcomes': [{'measure': 'Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications', 'timeFrame': 'up to 4-6 weeks after surgery', 'description': 'To investigate the association between the number of participants with complications and hospital length of stay(days)'}, {'measure': 'Change of hematology parameters', 'timeFrame': 'up to 4-6 weeks after surgery', 'description': 'change of hematology parameters value of Hb in g/dL,\n\n* ferritin in ng/ml\n* transferrin saturation in % (TSAT) after Ferinject® administration)'}, {'measure': 'Adverse event', 'timeFrame': 'up to 4-6 weeks after surgery', 'description': 'assessment of adverse effect with Ferinject® administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ferric carboxymaltose', 'Ferinject®', 'pancreatoduodenectomy'], 'conditions': ['Pancreatic Cancer', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '11910485', 'type': 'RESULT', 'citation': 'Park SJ, Kim SW, Jang JY, Lee KU, Park YH. Intraoperative transfusion: is it a real prognostic factor of periampullary cancer following pancreatoduodenectomy? World J Surg. 2002 Apr;26(4):487-92. doi: 10.1007/s00268-001-0254-6. Epub 2002 Feb 4.'}, {'pmid': '17330243', 'type': 'RESULT', 'citation': 'Yeh JJ, Gonen M, Tomlinson JS, Idrees K, Brennan MF, Fong Y. Effect of blood transfusion on outcome after pancreaticoduodenectomy for exocrine tumour of the pancreas. Br J Surg. 2007 Apr;94(4):466-72. doi: 10.1002/bjs.5488.'}, {'pmid': '1990875', 'type': 'RESULT', 'citation': 'Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5.'}, {'pmid': '6234037', 'type': 'RESULT', 'citation': 'Kaplan J, Sarnaik S, Gitlin J, Lusher J. Diminished helper/suppressor lymphocyte ratios and natural killer activity in recipients of repeated blood transfusions. Blood. 1984 Jul;64(1):308-10.'}, {'pmid': '3492188', 'type': 'RESULT', 'citation': 'Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function. III. Alterations in macrophage arachidonic acid metabolism. Arch Surg. 1987 Jan;122(1):56-60. doi: 10.1001/archsurg.1987.01400130062009.'}, {'pmid': '10924610', 'type': 'RESULT', 'citation': 'Innerhofer P, Tilz G, Fuchs D, Luz G, Hobisch-Hagen P, Schobersberger W, Nussbaumer W, Lochs A, Irschick E. Immunologic changes after transfusion of autologous or allogeneic buffy coat-poor versus WBC-reduced blood transfusions in patients undergoing arthroplasty. II. Activation of T cells, macrophages, and cell-mediated lympholysis. Transfusion. 2000 Jul;40(7):821-7. doi: 10.1046/j.1537-2995.2000.40070821.x.'}, {'pmid': '10029607', 'type': 'RESULT', 'citation': 'Ghio M, Contini P, Mazzei C, Brenci S, Barberis G, Filaci G, Indiveri F, Puppo F. Soluble HLA class I, HLA class II, and Fas ligand in blood components: a possible key to explain the immunomodulatory effects of allogeneic blood transfusions. Blood. 1999 Mar 1;93(5):1770-7.'}, {'pmid': '6125797', 'type': 'RESULT', 'citation': 'Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.'}, {'pmid': '2354408', 'type': 'RESULT', 'citation': 'Griffin JF, Smalley SR, Jewell W, Paradelo JC, Reymond RD, Hassanein RE, Evans RG. Patterns of failure after curative resection of pancreatic carcinoma. Cancer. 1990 Jul 1;66(1):56-61. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-6.'}]}, 'descriptionModule': {'briefSummary': 'This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.', 'detailedDescription': 'Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).\n\nSecondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥19 years old\n* anticipating PD\n* preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl\n* signed written informed consent\n\nExclusion Criteria:\n\n* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient\n* hypersensitivity to any component of the formulation\n* active severe infection/inflammation\n* history of transfusion, erythropoietin, \\>500 mg intravenous iron administration within 4 weeks prior to screening.\n* history of acquired iron overload.\n* MCV \\> 95µm3 or TSAT \\> 35%\n* patients with preoperative Hb\\<7 g/dl\n* pregnancy or lactation\n* decreased renal function (defined as creatinine clearance \\<50 L/min/1.73m2calculated by eGFR(MDRD))\n* chronic liver disease or increase of liver enzymes (ALT, AST) \\>5 times the upper limit of normal range'}, 'identificationModule': {'nctId': 'NCT02628860', 'acronym': 'FCM', 'briefTitle': 'Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy', 'orgStudyIdInfo': {'id': 'NCCCTS-13-709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferinject', 'description': 'Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \\<50 Kg .\n\nDosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride.\n\nStrength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.', 'interventionNames': ['Drug: Ferinject (Ferric Carboxymaltose)']}], 'interventions': [{'name': 'Ferinject (Ferric Carboxymaltose)', 'type': 'DRUG', 'otherNames': ['Ferinject'], 'description': 'Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \\<50 Kg .\n\nStudy drug may be administered as IV drip infusion or IV undiluted bolus injection.', 'armGroupLabels': ['Ferinject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Sang Jae Park, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch', 'investigatorFullName': 'Sang-Jae Park', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}