Study of AVE5026 at weight-adjusted doses in children with a CentralVenous Line

Conditions: Prevention of thromboembolism
MedDRA version: 14.1Level: LLTClassification code 10043566Term: ThromboembolismSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-005155-14-Outside-EU/EEA

Lead Sponsor: sanofi-aventis Recherche et Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 44

Inclusion Criteria

Male and female patient - age between = 38 gestational weeks and < 18 years
Central Venous Line implanted for an expected duration = 6 days from study enrolment
Patient hospitalized or able to receive daily injection for at least 6 days and provide plasma samples at Day 4, 5 and 6 at the pre-specified time points
Written informed consent signed by legal representative(s) in accordance with local regulation, and possibly assent form by the child (country/age specific)
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient for whom anticoagulant therapy is contraindicated
Planned treatment with other antithrombotic agents within 2 weeks prior to enrolment and during the course of the study
Any previous exposure to AVE5026 (eg. previous enrolment in the current study)
Documented history of heparin-induced thrombocytopenia
Severe thrombocytopenia (platelets < 50 x 10 000 000 000/L)
Active bleeding
Recent (less than 3 weeks prior to enrollment) brain, spinal or ophthalmologic surgery
Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure greater than 2 standard deviations above the age-related norm
Severe hepatic disease (e.i. more than 2.5 times the upper limit for age of hepatic enzymes)
Severe renal insufficiency (estimated creatinine clearance < 30 ml/min using the Schwartz formula)
Any condition that, in the opinion of the Investigator, would expose the patient to an unfavorable risk/benefit ratio
Presence or history of drug hypersensitivity
Any patient currently involved in another clinical trial with an investigational drug according to applicable regulations
Any patient or parent(s)/legal guardian(s) who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development
Any patient or parent(s)/legal guardian(s) who cannot be contacted in case of emergency
Pregnant or breast-feeding female
Female of childbearing potential who are unwilling to abstain from sexual intercourse and therefore are at risk of becoming pregnant and are not protected by highly effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Pharmacokinetics: Plasma concentrations of AVE5026.<br>Individual pharmacokinetic parameters of AVE5026 in children will be derived from a full population PK model building (including covariates assessment).<br><br>Pharmacodynamic activity (anti-Xa activity) of AVE5026.<br>Individual pharmacodynamic parameters of AVE5026 in children will be derived from a full population PK/PD model building (including covariates assessment).;Main Objective: To assess the pharmacokinetic and pharmacodynamic parameters<br>of AVE5026 (assessed from the anti-Xa activity of AVE5026) in<br>children in order to determine the dose to be assessed in the<br>subsequent clinical efficacy/safety study;Secondary Objective: To assess the tolerability of AVE5026 when administered at a<br>weight-adjusted, once daily dose for up to 30 days;Timepoint(s) of evaluation of this end point: 6 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety parameters including bleeding<br>Safety parameters including transfusions requirement<br>Safety parameters including hemoglobin, platelet count<br>Safety parameters including liver and renal laboratory data<br>Safety parameters including serious adverse events<br>Safety parameters including non-serious adverse events;Timepoint(s) of evaluation of this end point: up to 30+/- 2 days post treatment