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Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line

NCT01567904 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-05-03

No results posted yet for this study

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.

Conditions

  • Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL)

Interventions

DRUG

Semuloparin sodium

Solution for injection in single dose vials (10 mg/mL and 20 mg/mL) Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Hungary

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567904 on ClinicalTrials.gov