drugset / Trial / NCT01567904
Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line
Non-randomizedSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Semuloparin | Other / unclassified | — | Subcutaneous |
Indications
No indication recorded.