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Venous ThromboembolismPhase 2NCT02223260

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

A Phase 2 study testing dabigatran in people with Venous Thromboembolism, run by Boehringer Ingelheim at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year. Read more about this study

Who is it for?
Ages Up to 12 months
Conditions the study is for
Venous Thromboembolism
What is being tested?
dabigatran
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesin 3 countries
Study dates
Sep 2014to Feb 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonates and infants with aged < 12 months at Visit 1
  • Objective diagnosis of VTE
  • End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.
  • Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.

Who cannot join

  • Weight less than 3 kg at Visit 1
  • Conditions associated with an increased risk of bleeding
  • renal dysfunction
  • hepatic disease
  • Anemia or thrombocytopenia at screening

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Canada2 sites

  • 1160.105.10003 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.105.10002 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario

Other trials in Canada

France1 site

  • 1160.105.33001 Boehringer Ingelheim Investigational Site

    Paris

Other trials in France

Russia1 site

  • 1160.105.70005 Boehringer Ingelheim Investigational Site

    Kazan'

Other trials in Russia

About this study

Official title: Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old

The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

Read the detailed description

Purpose:

Being tested
dabigatran
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dabigatranDrug

    Experimental dose chosen based on age and weight

Study groups in NCT02223260
Study groupRoleWhat they receive
dabigatranExperimentalopen label arm with dabigatran oral liquid formulation as single dose
Receives: Drug: dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate

    Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.

    Measured: 2 hours (h) and 12h after drug administration on day 1

  2. Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    Measured: 2 h, and 12 h after dosing on day 1

  3. Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    Measured: 2 h, and 12 h after dosing on day 1

  4. Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    Measured: 2 h, and 12 h after dosing on day 1

  5. Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

  6. Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

  7. Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.

    Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

    dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

Secondary outcomes (6)

  1. PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.

    Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

  2. PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.

    Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

  3. PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.

    Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.

    Measured: baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1

  4. Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.

    Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) \& minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:

    Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered \& which was not directly attributable to the patient's underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding.

    Measured: Within two days after the administration of trial medication, up to 3 days

  5. Incidence of All AEs During the Treatment Period

    Percentage of patients with all adverse events (AEs) during the treatment period (including REP).

    Measured: Within two days after the administration of trial medication, up to 3 days

  6. Global Assessment of Acceptability and Tolerability of Study Medication

    The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).

    Measured: Day 1 (immediately after dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02223260
Sponsor's protocol ID
1160.105
Other IDs
2014-001259-22, 2014
Status last verified
Jul 2016
First submitted
21 Aug 2014
Last updated
20 Sep 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dabigatran in people with Venous Thromboembolism, run by Boehringer Ingelheim at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, France, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate (time frame: 2 hours (h) and 12h after drug administration on day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02223260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.

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