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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003328-12-AT
Enrollment
Unknown
Registered
2006-11-24
Start date
2006-12-11
Completion date
Unknown
Last updated
2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persons with Inflammatory Bowel Disease, thrombocytosis and iron deficiency

Interventions

Product Name: Ferinject Product Code: Vit-45 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use

Sponsors

Vifor Int.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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 •To evaluate the efficacy of FERINJECT® in normalizing iron deficiency •To evaluate the change of quality in life and disease activity •To evaluate the safety of FERINJECT® ;Primary end point(s): The primary efficacy endpoint is a decrease of the platelet counts >25% after 6 weeks.—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026