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Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)

NCT00882414 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-04-08

No results posted yet for this study

Summary

The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.

Conditions

  • Thrombocytosis
  • Iron-Deficiency Anemia

Interventions

DRUG

FERINJECT® (Ferric carboxymaltose)

FERINJECT® will be administered i.v. into a peripheral vein in the arm. 500 mg FERINJECT® will be diluted to a total volume of 100mL in 0.9% saline for infusion and administered over 15 minutes duration.

DRUG

Placebo

Placebo will be administered i.v. into a peripheral vein in the arm. A total volume of 100mL 0.9% saline will be administered over 15 minutes duration.

Sponsors & Collaborators

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Christoph Gasche, MD · Allgemeines KrankenHaus, Vienna, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Austria

Study Locations

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Entities

Drugs

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 NCT00882414 on ClinicalTrials.gov