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

• Conditions: Prevention of thromboembolism; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 15.1Level: LLTClassification code 10043566Term: ThromboembolismSystem Organ Class: 100000004866

• Registration Number: EUCTR2011-005155-14-SK
• Lead Sponsor: sanofi-aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-12
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• 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