Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01567904
Brief 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.
Detailed Description:
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.
Study:
NCT01567904
Study Brief:
Protocol Section:
NCT01567904