Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
NCT ID: NCT01428843
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2011-01-31
2014-12-31
Brief Summary
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Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.
The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ferrisat
Infusion of Ferrisat (50mg/ml) at inclusion under usual practices
FERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Placebo
Infusion of placebo at inclusion visit
PLACEBO
A single infusion of Glucose 5% solution during inclusion visit
Interventions
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FERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
PLACEBO
A single infusion of Glucose 5% solution during inclusion visit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
* Under anti-TNF therapy or indication for starting an anti-TNF therapy
* Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
* Iron deficiency anemia defined as:
* Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Guillaume SAVOYE, PhD
Role: PRINCIPAL_INVESTIGATOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Jean-Frédéric COLOMBEL, PhD
Role: STUDY_DIRECTOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Locations
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Chu Amiens
Amiens, , France
CHU CAEN
Caen, , France
Chu Clermont-Ferrand
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
CHRU Lille
Lille, , France
Chu Marseille - Hopital Nord
Marseille, , France
Chu Nantes
Nantes, , France
Hopital Saint Louis
Paris, , France
Hopital St Antoine
Paris, , France
Hopital Cochin
Paris, , France
CHU Bordeaux - Pessac
Pessac, , France
CHU LYON
Pierre-Bénite, , France
Chu Rennes
Rennes, , France
Chu Rouen
Rouen, , France
Chu Saint Etienne
Saint-Etienne, , France
Chu Toulouse
Toulouse, , France
Chu Tours
Tours, , France
Countries
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References
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Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. doi: 10.1046/j.1365-2036.2001.00930.x.
Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.
Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. doi: 10.1136/gut.8.2.107. No abstract available.
Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. doi: 10.1016/j.amjmed.2003.12.011.
Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53. doi: 10.1002/ibd.20285.
Gisbert JP, Gomollon F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x.
Other Identifiers
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2009-011316-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GETAID 2009-2
Identifier Type: -
Identifier Source: org_study_id
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