blood clot in the vein VTE
Conditions
Interventions
The initial doses of the study drug (FRAGMIN® dalteparin sodium) are:
* Participants who are ages newborn to less than 8 weeks will receive an
initial dose of 125 IU/kg twice-daily.
* Participants w
Venous thromboembolism
Children
Sponsors
Pfizer
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects meet inclusion if all of the following are true:;1. Have been objectively diagnosed with a venous thrombotic event documented using one of the following acceptable imaging modalities within 4 days of the Screening Visit: * - Compression ultrasound with Doppler [CUD];;* - Computed tomography with/without venography [CT/CTV];;* - Magnetic resonance imaging with/without venography [MRI/MRV];;* - Conventional venography [CV];;*- Ventilation-perfusion scan [V/Q] (for pulmonary artery);;* - Spiral CT angiography [SCTA];;* - Conventional pulmonary angiogram [CPA].;2. Are judged clinically to require anticoagulation therapy.;3. Are in the age range of *36 weeks gestation and
Exclusion criteria
Exclusion criteria: Subjects are excluded if any one of the following apply:;1. Weight *3.0 kg or >100 kg at Screening Visit;2. Platelet count * 50,000/mm (despite appropriate medical measures to support platelet count).;3. Received oral anticoagulant (OAC) therapy within 3 days of the Screening Visit.;4. History of administration of therapeutic doses of LMWH (low molecular weight heparin) or unfractionated heparin for a period of > 4 days (or > 8 doses of LMWH) for the qualifying VTE.;5. Received unfractionated heparin within 3 hours, or LMWH within 12 hours, of the first dose of dalteparin.;6. Acute VTE intervention which includes thrombolytic therapy.;7. Subjects with major bleeding or bleeding disorders such as Platelet Dysfunction, Protein Deficiency, Disseminated Intravascular coagulation (DIC), Factor Deficiency, Hemophilia, Idiopathic Thrombocytopenic Purpura (ITP) or Von Willebrand Disease at the time of the Screening Visit or an unacceptably high risk of bleeding, at the discretion of the investigator, should not be considered candidates.;8. Activated partial thromboplastin time (aPTT) *5 seconds above upper limit of normal (ULN), and that corrects to within normal limits upon 1:1 mixing with normal plasma.;9. Prothrombin time (PT) *2 seconds above ULN, and that corrects to within normal limits upon 1:1 mixing with normal plasma.;10. Creatinine clearance 1 month of age.;11. Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure > 99th percentile of age- and heightrelated norms.;12. History of heparin-induced thrombocytopenia (HIT). 13. Any condition in which the investigator feels the subject is unsafe or inappropriate for study participation. 14. Participation in other clinical studies involving investigational drug(s) within the past 30 days. 15. Insufficient subcutaneous tissue to facilitate subcutaneous drug administration. 16. Pregnant female subjects; breastfeeding female subjects; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of assigned treatment. 17. Unable or unwilling to comply with scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: * Determine the median dose of dalteparin (IU/kg) associated with the achievement of the therapeutic anti-Xa level (0.5-1.0 IU/mL) among subjects that achieved their therapeutic anti-Xa level duringthe dose adjustment phase, for each age cohort group; * Anti-Xa activity versus time profile following dalteparin treatment will be explored using a population PD analysis methodology. Population PD parameters such as clearance, volume of distribution, absorption rate constant will be estimated based on anti-Xa levels collected during dose adjustment phase, PD phase and follow-up phase. Age and other relevant covariates will be explored in the population PD analysis. 090177e187de79f3\Approved | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints (all are secondary): * Proportion of subjects achieving an anti Xa therapeutic range of 0.5 to 1.0 IU/mL during the Dose Adjustment Phase; * Proportion of subjects with objectively documented new or progressive symptomatic VTE during dalteparin treatment; * Proportions of subjects with progression, regression, resolution, or no change in the qualifying VTE during dalteparin treatment; * Time to first episode of recurrent VTE during dalteparin treatment. Safety Endpoints (all are secondary): * Proportion of subjects with major bleeding during dalteparin treatment; * Proportion of subjects with minor bleeding during dalteparin treatment; * Relationship between major bleeding event and the Anti-Xa level during dalteparin treatment if data permits; * Description of subjects' adverse events (AE) throughout the study period; * Summary of chemistry, hematology, vital signs and physical examinations; * Time to first major bleeding events during dalteparin treatment. | — |
Countries
The Netherlands
Outcome results
None listed