A multi-centre, randomized, controlled, single-blinded, phase II study to investigate the safety and efficacy of intravenous infusions of FERINJECT® versus placebo in patients with thrombocytosis secondary to iron deficiency and chronic inflammatory bowel disease - ThromboVIT
- Conditions
- Persons with Inflammatory Bowel Disease, thrombocytosis and iron deficiency
- Registration Number
- EUCTR2006-003328-12-AT
- Lead Sponsor
- Vifor Int.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1.Male or female, inpatient or outpatient, aged at least 16 years and not more than 60 years.
2.platelet count >450G/l
3.Transferrin saturation (TfS) <20% or ferritin < 100?g/l
4.Previously diagnosed inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.CDAI >220 9, CAI>6 10
2.Significant anemia (hemoglobin <10.5 g/dl)
3.Blood transfusions or iron therapy during the previous 4 weeks, or erythropoietin treatment within the 8 weeks prior to enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts;Secondary Objective: •To evaluate the effect of FERINJECT® on coagulation and platelet activation parameters <br>•To evaluate the efficacy of FERINJECT® in normalizing iron deficiency<br>•To evaluate the change of quality in life and disease activity<br>•To evaluate the safety of FERINJECT®<br>;Primary end point(s): The primary efficacy endpoint is a decrease of the platelet counts >25% after 6 weeks.
- Secondary Outcome Measures
Name Time Method