Prevention of thromboembolism MedDRA version: 14.1 Level: LLT Classification code 10043566 Term: Thromboembolism System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Semuloparin sodium
Product Code: AVE5026
Pharmaceutical Form: Solution for injection
INN or Proposed INN: semuloparin sodium
Current Sponsor code: AVE5026
Concentration unit: mg/ml milli
Sponsors
sanofi-aventis Recherche et Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patient - age between = 38 gestational weeks and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetic and pharmacodynamic parameters of AVE5026 (assessed from the anti-Xa activity of AVE5026) in children in order to determine the dose to be assessed in the subsequent clinical efficacy/safety study;Secondary Objective: To assess the tolerability of AVE5026 when administered at a weight-adjusted, once daily dose for up to 30 days;Primary end point(s): Pharmacokinetics: Plasma concentrations of AVE5026. Individual pharmacokinetic parameters of AVE5026 in children will be derived from a full population PK model building (including covariates assessment). Pharmacodynamic activity (anti-Xa activity) of AVE5026. Individual pharmacodynamic parameters of AVE5026 in children will be derived from a full population PK/PD model building (including covariates assessment).;Timepoint(s) of evaluation of this end point: 6 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety parameters including bleeding Safety parameters including transfusions requirement Safety parameters including hemoglobin, platelet count Safety parameters including liver and renal laboratory data Safety parameters including serious adverse events Safety parameters including non-serious adverse events;Timepoint(s) of evaluation of this end point: up to 30+/- 2 days post treatment | — |
Countries
Brazil, Canada, Guatemala, Hong Kong, Hungary, Israel, Mexico, Peru, Romania, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Turkey
Outcome results
None listed