Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Pharmacokinetics of Tranexamic Acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers.

    Summary
    EudraCT number
    		 2019-000285-38
    Trial protocol
    		 FR  
    Global end of trial date
    14 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2022
    First version publication date
    08 Sep 2022
    Other versions
    Summary report(s)
    		 Publication

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    APHP190020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03777488
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 code sponsor LSHTM: 2018/KEP/205
    Sponsors
    Sponsor organisation name
    LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE
    Sponsor organisation address
    Keppel Street, LONDON, United Kingdom, WC1E 7HT
    Public contact
    Collette Barrow , LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE , 44 0207 299 4684, woman2@lshtm.ac.uk
    Scientific contact
    Pr. Haleema Shakur-Still, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE , Haleema.Shakur-Still@lshtm.ac.uk
    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
    Final
    Date of interim/final analysis
    28 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the pharmacokinetics of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration
    Protection of trial subjects
    - Inclusion / exclusion criteria; - At the inclusion visit, all women must have a pregnancy test (urine βhCG) done which must be negative to continue. Participants medical history will be checked to ensure there are no changes since V0 visit; - After drug administration, pain assessment using a Visual Analogue Scale (VAS) and vital signs were recorded during 8 hours; - The patient is seen the next day.
    Background therapy
    		 No background therapy.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    03 Jun 2019
    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
    France: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Healthy volunteers will be recruited by advertisement in universities or website to the general public. A first contact by phone or mail will be done by investigator in order to verify main eligibility criteria and give information about the study. If volunteer agrees to consider participation, an appointment for screening visit will be scheduled.

    Pre-assignment
    Screening details
    		 The screening visit will take place between 1 and 7 days before the inclusion visit.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic acid Group 1
    Arm description
    		 Participants will receive tranexamic acid in the following order: • First Dose: Intravenous • Second Dose: Intramuscular • Third Dose: Oral
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Arm title
    		 Tranexamic acid Group 2
    Arm description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Arm title
    		 Tranexamic acid Group 3
    Arm description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Arm title
    		 Tranexamic acid Group 4
    Arm description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Arm title
    		 Tranexamic acid Group 5
    Arm description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Arm title
    		 Tranexamic acid Group 6
    Arm description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Solution for injection
    Routes of administration
    Intramuscular use, Intravenous use, Oral use
    Dosage and administration details
    Drug: Tranexamic Acid 1 gram intravenously Intravenous tranexamic acid crossover to oral and intramuscular arms Drug: Tranexamic acid 2 grams oral solution Oral tranexamic acid crossover to intravenous and intramuscular arms Drug: Tranexamic acid 1 gram intramuscular Intramuscular tranexamic acid crossover to oral and intravenous arms

    Number of subjects in period 1
    		Tranexamic acid Group 1 Tranexamic acid Group 2 Tranexamic acid Group 3 Tranexamic acid Group 4 Tranexamic acid Group 5 Tranexamic acid Group 6
    Started
    3
    2
    3
    2
    2
    3
    Completed
    3
    2
    3
    2
    2
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Tranexamic acid Group 1
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: • First Dose: Intravenous • Second Dose: Intramuscular • Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 2
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 3
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 4
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous

    Reporting group title
    Tranexamic acid Group 5
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 6
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous

    Reporting group values
    		 Tranexamic acid Group 1 Tranexamic acid Group 2 Tranexamic acid Group 3 Tranexamic acid Group 4 Tranexamic acid Group 5 Tranexamic acid Group 6 Total
    Number of subjects
    		 3 2 3 2 2 3 15
    Age categorical
    The 11 female and four male study participants had a median age of 25 yr and a median BW of 64.2 kg.
    Units: Subjects
        Adults (18-64 years)
    		 3 2 3 2 2 3 15
    Gender categorical
    The 11 female and four male study participants had a median age of 25 yr and a median BW of 64.2 kg.
    Units: Subjects
        Female
    		 3 2 2 1 1 2 11
        Male
    		 0 0 1 1 1 1 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Tranexamic acid Group 1
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: • First Dose: Intravenous • Second Dose: Intramuscular • Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 2
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 3
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 4
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous

    Reporting group title
    Tranexamic acid Group 5
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 6
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous

    Primary: Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)

    		 Close Top of page
    End point title
    		 Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous) [1]
    End point description
    The median time to reach a concentration of 10 mg.L-1 was 1 min for the IV route, 3.5 min for the IM route, and 66 min for the oral route, although with the oral route the target concentration was reached in only 11 of 15 patients. The median maximum concentration was 54.6, 34.3, and 12.7 mg.L-1 for the IV, IM, and oral routes, respectively. Note: standard deviation is non applicable so set to 0.
    End point type
    Primary
    End point timeframe
    24 hours
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Final data analysis involved determination of pharmacokinetic parameters over time. No formal statistical analysis was required relating to the primary endpoint.
    End point values
    		 Tranexamic acid Group 1 Tranexamic acid Group 2 Tranexamic acid Group 3 Tranexamic acid Group 4 Tranexamic acid Group 5 Tranexamic acid Group 6
    Number of subjects analysed
    3
    2
    3
    2
    2
    3
    Units: µg/mL
        arithmetic mean (standard deviation)
    54.6 ± 0
    54.6 ± 0
    54.6 ± 0
    54.6 ± 0
    54.6 ± 0
    54.6 ± 0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    3 months maximum
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Tranexamic acid Group 1
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: • First Dose: Intravenous • Second Dose: Intramuscular • Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 2
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 3
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral

    Reporting group title
    Tranexamic acid Group 4
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous

    Reporting group title
    Tranexamic acid Group 5
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular

    Reporting group title
    Tranexamic acid Group 6
    Reporting group description
    		 Participants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous

    Serious adverse events
    		 Tranexamic acid Group 1 Tranexamic acid Group 2 Tranexamic acid Group 3 Tranexamic acid Group 4 Tranexamic acid Group 5 Tranexamic acid Group 6
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tranexamic acid Group 1 Tranexamic acid Group 2 Tranexamic acid Group 3 Tranexamic acid Group 4 Tranexamic acid Group 5 Tranexamic acid Group 6
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    3 / 3 (100.00%)
    2 / 2 (100.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    2 / 2 (100.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    1
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0

    More information

    		 Close 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? Yes
    Date
    Interruption
    Restart date
    17 Mar 2020
    Interruption of inclusions during the first COVID-19 lockdown. No patient were in follow-up during this period
    12 Jun 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Main limitations are related to the study population, as young and healthy volunteers were included. We therefore did not investigate the effect of age or BW through a wide range, or the effect of renal impairment and other clinical conditions.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34998508
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 21:52:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA