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

Primary Purpose

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

Status

Terminated

Phase

Phase 2

Locations

Hungary

Study Type

Interventional

Intervention

Semuloparin sodium

About this trial

This is an interventional prevention trial for Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL) focused on measuring thrombosis, Central Venous Line, CVL

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria :

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).

Exclusion criteria:

Patient for whom anticoagulant therapy was contraindicated;
Planned treatment with other antithrombotic agents within 2 weeks prior to enrolment and during the course of the study;
Any previous exposure to Semuloparin (e.g. previous enrolment in the current study);
Documented history of heparin-induced thrombocytopenia;
Severe thrombocytopenia (platelets <50 x 109/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 have exposed 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, was 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 could not be contacted in case of emergency;
Pregnant or breast-feeding female;
Female of childbearing potential who were unwilling to abstain from sexual intercourse and therefore were at risk of becoming pregnant and were not protected by highly effective contraceptive method of birth control and/or who were unwilling or unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Investigational Site Number 348001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Age group from 12 to 18 (<) years

Age group from 6 to 12 (<) years

Age group from 2 to 6 (<) years

Age group from 3 months to 2 (<) years

Age group from birth to 3 (<) months

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Outcomes

Primary Outcome Measures

Pharmacokinetics: Plasma concentrations of Semuloparin

A validated anti-Xa chromogenic enzyme assay, with addition of AT-III in excess was to be used to assess plasma concentrations of semuloparin. A full population PK model of semuloparin in children (including covariates assessment) was to be established and individual pharmacokinetic parameters were be estimated.

Pharmacodynamic activity (anti-Xa activity) of Semuloparin

A validated anti-Xa chromogenic enzyme assay, without addition of AT-III in excess, was to be used to assess pharmacodynamic activity (factor Xa inhibition) of semuloparin. A full population PK/PD model of semuloparin in children (including covariates assessment) was to be established and individual pharmacodynamic parameters were to be estimated.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01567904

First Posted

March 28, 2012

Last Updated

April 4, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01567904

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication

Study Start Date

May 2012 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

thrombosis, Central Venous Line, CVL

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Age group from 12 to 18 (<) years

Arm Type

Experimental

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Arm Title

Age group from 6 to 12 (<) years

Arm Type

Experimental

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Arm Title

Age group from 2 to 6 (<) years

Arm Type

Experimental

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Arm Title

Age group from 3 months to 2 (<) years

Arm Type

Experimental

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Arm Title

Age group from birth to 3 (<) months

Arm Type

Experimental

Arm Description

Semuloparin sodium, weight-adjusted dose once daily for 6-30 days

Intervention Type

Drug

Intervention Name(s)

Semuloparin sodium

Other Intervention Name(s)

AVE5026

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetics: Plasma concentrations of Semuloparin

Description

Time Frame

6 samples; 0.5-1h and 6h after D4 injection, 1.5-4h and 12h after D5 injection, just before and 8h after D6 injection

Title

Pharmacodynamic activity (anti-Xa activity) of Semuloparin

Description

Time Frame

6 samples; 0.5-1h and 6h after D4 injection, 1.5-4h and 12h after D5 injection, just before and 8h after D6 injection

Secondary Outcome Measure Information:

Title

Safety parameters including bleeding

Time Frame