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Completed

NCT Number: NCT02223260

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

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1160.105.10002 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada

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About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

dabigatran

Drug

Experimental dose chosen based on age and weight

Primary outcomes

  1. 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

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

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

    Time frame: 2 h, and 12 h after dosing on day 1

    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.

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

    Time frame: 2 h, and 12 h after dosing on day 1

    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.

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

    Time frame: 2 h, and 12 h after dosing on day 1

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  5. Incidence of All AEs During the Treatment Period

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

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

  6. Global Assessment of Acceptability and Tolerability of Study Medication

    Time frame: Day 1 (immediately after dosing)

    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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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