A randomized, controlled, single-blinded, phase II study to investigate the safety and efficacy of intravenous infusions of FERINJECT® versus placebo on platelet activity in patients with iron deficiency and chronic inflammatory bowel disease. The ThromboAct trial

A randomized, controlled, single-blinded, phase II study to investigate the safety and efficacy of intravenous infusions of FERINJECT® versus placebo on platelet activity in patients with iron deficiency and chronic inflammatory bowel disease. The ThromboAct trial - ThromboAct

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004561-33-AT

Enrollment

Registered

2014-05-12

Start date

2014-05-23

Completion date

Unknown

Last updated

2022-03-28

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

Conditions

iron deficiency in chronic inflammatory bowel disease

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ferric carboxymaltose CAS Number: 9007-72-01 Current Sponsor code: Vifor i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, inpatient or outpatient, aged at least 18 years and not more than 60 years. 2. Transferrin saturation (TfS) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Harvey Bradshaw Index >7 (10) , Mayo Score >5 (11) 2. Significant anemia (hemoglobin 20 mg/L 12. Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator. Known hypersensitivity to FERINJECT® 13. Positive for HIV 1/HIV 2 antibodies (anti HIV) (HIV: human immunodeficiency virus). 14. Positive for hepatitis B surface-antigen (HBsAg), hepatitis C virus antibody (anti HCV) and evidence for active hepatitis, i.e., abnormal liver function test (LFT) results.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the efficacy of iron in comparison to placebo in reducing platelet activity as measured by platelet aggregation;Secondary Objective: • To evaluate the effect of iron in comparison to placebo on markers of platelet activation and platelets counts • To evaluate the efficacy of iron in comparison to placebo in normalizing iron deficiency • The evaluate the effect of iron in comparison to placebo on megakaryocytic growth factors • To evaluate the change of disease activity • To evaluate the safety of this treatment ;Primary end point(s): The primary efficacy endpoint is the change in platelet aggregation as measured by platelet aggregometry. ;Timepoint(s) of evaluation of this end point: week 4	—

Measure

Time frame

Main Objective: • To evaluate the efficacy of iron in comparison to placebo in reducing platelet activity as measured by platelet aggregation;Secondary Objective: • To evaluate the effect of iron in comparison to placebo on markers of platelet activation and platelets counts • To evaluate the efficacy of iron in comparison to placebo in normalizing iron deficiency • The evaluate the effect of iron in comparison to placebo on megakaryocytic growth factors • To evaluate the change of disease activity • To evaluate the safety of this treatment ;Primary end point(s): The primary efficacy endpoint is the change in platelet aggregation as measured by platelet aggregometry. ;Timepoint(s) of evaluation of this end point: week 4

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Secondary

Measure	Time frame
Secondary end point(s): • Markes of platelet activity (p-selectin expression on platelets, p-selectin in serum, sCD40L) and platelet counts. • Change in megakaryocytic growth factors such as thrombopoietin and Interleukin-3 • Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin) • Change in disease activity (Harvey-Bradshaw index and Mayoscore without endoscopy) • Change in inflammation parameters such as C-reactive protein, ESR, IL-6 and IL-11 and calprotectin. ;Timepoint(s) of evaluation of this end point: week 4	—

Measure

Time frame

Secondary end point(s): • Markes of platelet activity (p-selectin expression on platelets, p-selectin in serum, sCD40L) and platelet counts. • Change in megakaryocytic growth factors such as thrombopoietin and Interleukin-3 • Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin) • Change in disease activity (Harvey-Bradshaw index and Mayoscore without endoscopy) • Change in inflammation parameters such as C-reactive protein, ESR, IL-6 and IL-11 and calprotectin. ;Timepoint(s) of evaluation of this end point: week 4

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Countries

Austria

Contacts

Public ContactMedical University of Vienna, Depar

Medical University of Vienna, Department for

00431404004735

Outcome results

None listed

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