Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL)Phase 2NCT01567904
Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line
A Phase 2 study testing Semuloparin sodium in people with Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL), run by Sanofi at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL)
- What is being tested?
- Semuloparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- May 2012to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- Semuloparin sodium
- Keywords
- thrombosis, Central Venous Line, CVL
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semuloparin sodiumDrug
Also called AVE5026
Solution for injection in single dose vials (10 mg/mL and 20 mg/mL)
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Age group from 12 to 18 (<) years | Experimental | Semuloparin sodium, weight-adjusted dose once daily for 6-30 days Receives: Drug: Semuloparin sodium |
| Age group from 6 to 12 (<) years | Experimental | Semuloparin sodium, weight-adjusted dose once daily for 6-30 days Receives: Drug: Semuloparin sodium |
| Age group from 2 to 6 (<) years | Experimental | Semuloparin sodium, weight-adjusted dose once daily for 6-30 days Receives: Drug: Semuloparin sodium |
| Age group from 3 months to 2 (<) years | Experimental | Semuloparin sodium, weight-adjusted dose once daily for 6-30 days Receives: Drug: Semuloparin sodium |
| Age group from birth to 3 (<) months | Experimental | Semuloparin sodium, weight-adjusted dose once daily for 6-30 days Receives: Drug: Semuloparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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 outcomes (6)
Safety parameters including bleeding
Measured: up to 30+/- 2 days post treatment
Safety parameters including transfusions requirement
Measured: up to 30+/- 2 days post treatment
Safety parameters including hemoglobin, platelet count
Measured: up to 30+/- 2 days post treatment
Safety parameters including liver and renal laboratory data
Measured: up to 30+/- 2 days post treatment
Safety parameters including serious adverse events
Measured: up to 30+/- 2 days post treatment
Safety parameters including non-serious adverse events
Measured: up to 30+/- 2 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567904
- Sponsor's protocol ID
- PKM11204
- Other IDs
- 2011-005155-14, U1111-1115-8281
- Status last verified
- Apr 2016
- First submitted
- 28 Mar 2012
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01567904
- Acronym / sponsor ID
- PKM11204
- Keywords
- thrombosis, Central Venous Line, CVL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Age group from 12 to 18 (<) years | Experimental | Drug: Semuloparin sodiumSemuloparin sodium, weight-adjusted dose once daily for 6-30 days |
| Age group from 6 to 12 (<) years | Experimental | Drug: Semuloparin sodiumSemuloparin sodium, weight-adjusted dose once daily for 6-30 days |
| Age group from 2 to 6 (<) years | Experimental | Drug: Semuloparin sodiumSemuloparin sodium, weight-adjusted dose once daily for 6-30 days |
| Age group from 3 months to 2 (<) years | Experimental | Drug: Semuloparin sodiumSemuloparin sodium, weight-adjusted dose once daily for 6-30 days |
| Age group from birth to 3 (<) months | Experimental | Drug: Semuloparin sodiumSemuloparin sodium, weight-adjusted dose once daily for 6-30 days |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semuloparin sodiumAlso: AVE5026Solution for injection in single dose vials (10 mg/mL and 20 mg/mL) Subcutaneous injection | Drug | Age group from 12 to 18 (<) years, Age group from 2 to 6 (<) years, Age group from 3 months to 2 (<) years, Age group from 6 to 12 (<) years, Age group from birth to 3 (<) months |
Primary outcome
Pharmacokinetics: Plasma concentrations of Semuloparin
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
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
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
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.
6 secondary outcomes
Safety parameters including bleeding
Time frame: up to 30+/- 2 days post treatment
Safety parameters including transfusions requirement
Time frame: up to 30+/- 2 days post treatment
Safety parameters including hemoglobin, platelet count
Time frame: up to 30+/- 2 days post treatment
Safety parameters including liver and renal laboratory data
Time frame: up to 30+/- 2 days post treatment
Safety parameters including serious adverse events
Time frame: up to 30+/- 2 days post treatment
Safety parameters including non-serious adverse events
Time frame: up to 30+/- 2 days post treatment
Results and safety
The study was stopped early (reason given: Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semuloparin sodium in people with Thrombosis Prophylaxis (Risk of Thrombosis Due to Central Venous Line (CVL), run by Sanofi at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision from Sanofi to withdraw on a worldwide basis the Marketing Authorisation Applications for Semuloparin sodium in the adult indication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Plasma concentrations of Semuloparin (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.