Clinical Trial Results:
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

Trial information Top of page
Trial identification
Sponsor protocol code	ThromboAct
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Medical University of Vienna
Sponsor organisation address	Spitalgasse 23, Vienna, Austria,
Public contact	Medical University of Vienna, Depar, Medical University of Vienna, Department for, stefanie.dabsch@meduniwien.ac.at
Scientific contact	Medical University of Vienna, Depar, Medical University of Vienna, Department for, stefanie.dabsch@meduniwien.ac.at
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Interim
Date of interim/final analysis	16 Feb 2021
Is this the analysis of the primary completion data?	Yes
Primary completion date	06 Sep 2016
Global end of trial reached?	Yes
Global end of trial date	06 Sep 2016
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	• To evaluate the efficacy of iron in comparison to placebo in reducing platelet activity as measured by platelet aggregation
Protection of trial subjects	anonymization of data Insurance
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	01 Apr 2015
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Austria: 40
Worldwide total number of subjects	40
EEA total number of subjects	40
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	40
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Patient were recruited out of routine visits
Pre-assignment
Screening details	complete blood Count, questionnaire to screen patients
Period 1
Period 1 title	overall trial (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Single blind
Roles blinded	Subject
Blinding implementation details	Blinding was done via covering Infusion line and infusion
Arms
Are arms mutually exclusive	Yes
Arm title	Iron
Arm description	1000mg iron carboxymaltose Infusion at week 0
Arm type	Active comparator
Investigational medicinal product name	iron carboxymaltose
Investigational medicinal product code
Other name
Pharmaceutical forms	Concentrate and solvent for solution for infusion
Routes of administration	Intravenous use
Dosage and administration details	1000mg diluted in 250ml Sodium Chloride 0.9%
Arm title	Placebo
Arm description	Placebo control
Arm type	Placebo
Investigational medicinal product name	Sodium Chloride
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	250ml Sodium Chloride 0.9%
Number of subjects in period 1 Iron Placebo Started 20 20 Completed 20 20

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	overall trial
Reporting group description	-
Reporting group values overall trial Total Number of subjects 40 40 Age categorical Units: Subjects     In utero 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0     Newborns (0-27 days) 0 0     Infants and toddlers (28 days-23 months) 0 0     Children (2-11 years) 0 0     Adolescents (12-17 years) 0 0     Adults (18-64 years) 40 40     From 65-84 years 0 0     85 years and over 0 0 Gender categorical Units: Subjects     Female 25 25     Male 15 15

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Iron
Reporting group description	1000mg iron carboxymaltose Infusion at week 0
Reporting group title	Placebo
Reporting group description	Placebo control

End points Top of page

Primary: Change in Platelet aggregometry Top of page
End point title	Change in Platelet aggregometry
End point description
End point type	Primary
End point timeframe	Week 4 compared to baseline week 9
End point values Iron Placebo Number of subjects analysed 20 20 Units: area under the curve     median (inter-quartile range (Q1-Q3)) -108 (-208 to -61) 12 (-151 to 135)
Statistical analysis title	Mediantest
Comparison groups	Placebo v Iron
Number of subjects included in analysis	40
Analysis specification	Post-hoc
Analysis type	superiority
P-value	< 0.05
Method	meridian
Confidence interval

Primary: Change in Platelet aggregometry Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Within study period
Adverse event reporting additional description	all adverse events: not-relateted, probably related, possibly related
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	19.1
Reporting groups
Reporting group title	Placebo
Reporting group description	Placebo group
Reporting group title	Iron
Reporting group description	Group treated with intravenous iron
Serious adverse events Placebo Iron Total subjects affected by serious adverse events      subjects affected / exposed 0 / 20 (0.00%) 0 / 20 (0.00%)      number of deaths (all causes) 0 0      number of deaths resulting from adverse events 0 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Placebo Iron Total subjects affected by non serious adverse events      subjects affected / exposed 2 / 20 (10.00%) 4 / 20 (20.00%) General disorders and administration site conditions Fever      subjects affected / exposed 0 / 20 (0.00%) 3 / 20 (15.00%)      occurrences all number 0 3 Infections and infestations common cold      subjects affected / exposed 2 / 20 (10.00%) 1 / 20 (5.00%)      occurrences all number 2 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

More information Top of page