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Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

NCT01428843 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-06-23

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

FERRISAT

A single infusion of 50 mg/ml of Ferrisat during inclusion visit.

DRUG

PLACEBO

A single infusion of Glucose 5% solution during inclusion visit

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Guillaume SAVOYE, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Jean-Frédéric COLOMBEL, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428843 on ClinicalTrials.gov