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Trial record 20 of 332 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT02223260
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dabigatran Phase 2

Detailed Description:
Purpose:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dabigatran
open label arm with dabigatran oral liquid formulation as single dose
Drug: dabigatran
Experimental dose chosen based on age and weight




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223260


Locations
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Canada, Ontario
1160.105.10002 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Canada, Quebec
1160.105.10003 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
France
1160.105.33001 Boehringer Ingelheim Investigational Site
Paris, France
Russian Federation
1160.105.70005 Boehringer Ingelheim Investigational Site
Kazan, Russian Federation
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02223260     History of Changes
Other Study ID Numbers: 1160.105
2014-001259-22 ( EudraCT Number: EudraCT )
First Posted: August 22, 2014    Key Record Dates
Results First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Dabigatran
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants