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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011316-38 | EudraCT Number |
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Lack of enrollment
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Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrisat | Active Comparator | Infusion of Ferrisat (50mg/ml) at inclusion under usual practices |
|
| Placebo | Placebo Comparator | Infusion of placebo at inclusion visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FERRISAT | Drug | A single infusion of 50 mg/ml of Ferrisat during inclusion visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of hemoglobin | Efficacy of one-shot perfusion of Ferrisat (Iron supplementation) | 6 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Ferrisat | At Inclusion | |
| Improvement of quality of life | 6 weeks after perfusion |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume SAVOYE, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Jean-Frédéric COLOMBEL, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Amiens | 80054 | France | |||
| CHU CAEN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11284771 | Background | 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. | |
| 16673554 | Background | 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. |
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| PLACEBO | Drug | A single infusion of Glucose 5% solution during inclusion visit |
|
|
| Caen |
| 14033 |
| France |
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hopital Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| CHRU Lille | Lille | France |
| Chu Marseille - Hopital Nord | Marseille | 13915 | France |
| Chu Nantes | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital St Antoine | Paris | 75012 | France |
| Hopital Cochin | Paris | 75014 | France |
| CHU Bordeaux - Pessac | Pessac | 33700 | France |
| CHU LYON | Pierre-Bénite | 69495 | France |
| Chu Rennes | Rennes | 35033 | France |
| Chu Rouen | Rouen | 76031 | France |
| Chu Saint Etienne | Saint-Etienne | 42270 | France |
| Chu Toulouse | Toulouse | 31403 | France |
| Chu Tours | Tours | 37044 | France |
| 6022337 | Background | 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. |
| 15050885 | Result | 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. |
| 17985376 | Result | 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. |
| 18477354 | Result | 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. |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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