Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT01567904
Status:
TERMINATED
Last Update Posted:
2016-05-03
First Post:
2012-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line
Sponsor:
Sanofi
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: