Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02223260
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Months
Study:
NCT02223260
Study Brief:
Protocol Section:
NCT02223260