NCT02223260

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 20, 2016

Completed
Last Updated

September 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

August 21, 2014

Results QC Date

July 28, 2016

Last Update Submit

July 28, 2016

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (7)

  • 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.

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

  • 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.

    2 h, and 12 h after dosing on day 1

  • 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.

    2 h, and 12 h after dosing on day 1

  • 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.

    2 h, and 12 h after dosing on day 1

  • 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.

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

  • 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.

    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 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.

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

Secondary Outcomes (6)

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

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

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

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

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

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

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

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

  • Incidence of All AEs During the Treatment Period

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

  • +1 more secondary outcomes

Study Arms (1)

dabigatran

EXPERIMENTAL

open label arm with dabigatran oral liquid formulation as single dose

Drug: dabigatran

Interventions

dabigatranDRUG

Experimental dose chosen based on age and weight

dabigatran

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

1160.105.10002 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1160.105.10003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.105.33001 Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.105.70005 Boehringer Ingelheim Investigational Site

Kazan', Russia

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

September 20, 2016

Results First Posted

September 20, 2016

Record last verified: 2016-07

Locations

CA(2)RU(1)FR(1)