Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL) Clinical Trial
Official title:
An Open-label, Pharmacokinetic, Pharmacodynamic, and Tolerability Study of AVE5026 Administered at Weight-adjusted Doses to Patients Less Than 18 Years of Age With a Central Venous Line (CVL)
Primary Objective:
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin
(assessed from the anti-Xa activity of Semuloparin) in children in order to determine the
dose to be assessed in a clinical efficacy/safety study in this population.
Secondary Objective:
- To assess the tolerability of Semuloparin when administered at a weight-adjusted, once
daily dose for up to 30 days in patients less than 18 years of age with central venous line.
The maximum study duration for a participant was 68 days broken down as follows:
- Screening period: up to 6 days,
- Treatment period: minimum 6 days and maximum 30 days,
- Follow-up period with an end of study visit performed 4 weeks (30 +/-2 days) post
treatment.
Enrollment staggered by age group starting with the older children (≥12 years). In each
younger age group, enrolment was planned to initiate only following a review by the Data
Monitoring Committee (DMC) of the clinical safety data and available PK and PD data from the
first 3 out of 7 children from the previous older age group. Enrollment of infants <3 months
was planned to initiate after recruitment of all patients ≥3 months had been completed and
all data analyzed by the DMC.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention