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
Summary
|
|
EudraCT number |
2011-004561-33 |
Trial protocol |
AT |
Global end of trial date |
06 Sep 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
19 Mar 2021
|
First version publication date |
19 Mar 2021
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
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
|
|
||||||||||
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%
|
|||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
overall trial
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
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 point title |
Change in Platelet aggregometry | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4 compared to baseline week 9
|
||||||||||||
|
|||||||||||||
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 |
|
||||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||
|
|
|||
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 |