Inflammatory Bowel Disease

FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

NCT00810030 | PHASE 3 | INTERVENTIONAL

The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.

1 Sites

484 Participants

Recruiting

18 Years

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SUBMIT

AKH Vienna, University clinic of Int Medizin III

Vienna,Austria,1090

Study Eligibility Criteria

Inclusion Criteria

* Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.

Exclusion Criteria

* Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
* Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
* Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
* Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
* Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.
* Individuals with known or suspected impairment of the immune system.

Additional Studies

Additional studies can be found at ClinicalTrials.gov