Phase 2
Completed N=8
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
Source: ClinicalTrials.gov NCT02223260 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate — 120.0; 60.4 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate |
120.0; 60.4 | — |
| PRIMARY Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
78.9; 62.8 | — |
| PRIMARY Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
101; 66.9 | — |
| PRIMARY Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
48.7; 38.6 | — |
| PRIMARY Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
1.86; 1.47 | — |
| PRIMARY Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
2.42; 1.63 | — |
| PRIMARY Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. |
1.59; 1.26 | — |
| SECONDARY PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values. |
0.752 | — |
| SECONDARY PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values. |
0.858 | — |
| SECONDARY PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values. |
0.920 | — |
| SECONDARY Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period. |
0.0 | — |
| SECONDARY Incidence of All AEs During the Treatment Period |
0.0 | — |
| SECONDARY Global Assessment of Acceptability and Tolerability of Study Medication |
75.0; 12.5; 0.0; 12.5; 0.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02223260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.