E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
treatment of blood clot in the veins |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066899 |
E.1.2 | Term | Venous thromboembolism |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
To investigate tolerability and safety of dabigatran etexilate solution in newborns and infants aged less than 1 year |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: day 1
2: day 1
3: day 1
4: day 1 |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: day 1
2: up to day 3
3: up tp day 3
4: day 1
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Canada |
France |
Italy |
Singapore |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 7 |