Tolerability , PK/PD and safety of dabigatran etexilate oral liquid formulation in children < 1 year of age

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001259-22-AT

Enrollment

Registered

2014-07-02

Start date

2014-08-05

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

venous thrombotic event MedDRA version: 17.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Interventions

Product Name: dabigatran etexilate Product Code: BIBR 1048 MS Pharmaceutical Form: Oral solution INN or Proposed INN: DABIGATRAN ETEXILATE Current Sponsor code: BIBR 1048 MS Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Neonates and infants with aged =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To investigate tolerability and safety of dabigatran etexilate solution in newborns and infants aged less than 1 year;Main Objective: To confirm dabigatran etexilate dosing algorithm for newborns and infants aged less than 1 year and to assess comparable PK/PD relationship to older children and adults;Primary end point(s): 1: Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate 2: Central measurement of activated Partial Thromboplastin Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. 3: Central measurement of AntiFactor IIa activity (diluted thrombin time) at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. 4: Central measurement of Ecarin Clotting Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. ;Timepoint(s) of evaluation of this end point: 1: day 1 2: day 1 3: day 1 4: day 1	—

Measure

Time frame

Secondary Objective: To investigate tolerability and safety of dabigatran etexilate solution in newborns and infants aged less than 1 year;Main Objective: To confirm dabigatran etexilate dosing algorithm for newborns and infants aged less than 1 year and to assess comparable PK/PD relationship to older children and adults;Primary end point(s): 1: Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate 2: Central measurement of activated Partial Thromboplastin Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. 3: Central measurement of AntiFactor IIa activity (diluted thrombin time) at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. 4: Central measurement of Ecarin Clotting Time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. ;Timepoint(s) of evaluation of this end point: 1: day 1 2: day 1 3: day 1 4: day 1

—

Secondary

Measure	Time frame
Secondary end point(s): 1: PK-PD relationship 2: Incidence of all bleeding events (major and minor) during the treatment period (including residual effect period (REP)) 3: Incidence of all adverse events during the treatment period (including REP) 4: Global assessment of acceptability and tolerability of the study medication ;Timepoint(s) of evaluation of this end point: 1: day 1 2: up to day 3 3: up tp day 3 4: day 1	—

Measure

Time frame

Secondary end point(s): 1: PK-PD relationship 2: Incidence of all bleeding events (major and minor) during the treatment period (including residual effect period (REP)) 3: Incidence of all adverse events during the treatment period (including REP) 4: Global assessment of acceptability and tolerability of the study medication ;Timepoint(s) of evaluation of this end point: 1: day 1 2: up to day 3 3: up tp day 3 4: day 1

—

Countries

Austria, Canada, France, Italy, Singapore, United States

Contacts

Public ContactLilija Kircheis

Boehringer Ingelheim RCV GmbH & Co KG

lilija.kircheis@boehringer-ingelheim.com+431801057705

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026