Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line
Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin
[AVE5026] (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.