Status:
TERMINATED
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- 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
- \-
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01428843
Start Date
January 1 2011
End Date
December 1 2014
Last Update
June 23 2015
Active Locations (18)
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1
Chu Amiens
Amiens, France, 80054
2
CHU CAEN
Caen, France, 14033
3
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
4
Hopital Beaujon
Clichy, France, 92110