ThrombosisPhase 1NCT00622115
Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)
A Phase 1 study testing Enoxaparin in people with Thrombosis, run by Sanofi at 1 site in France.
Trial summary
Primary objective: to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Nov 2007
- Phase
- Phase 1
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- Male and female subjects, between 40 and 60 years of age
- Body weight between 50 kg and 90 kg if male and between 40 and 80 kg if female with Body Mass Index (BMI) between 18 and 29 kg/m2
- Health Status:
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Subject with hypertension, hypo- or hyperthyroidism or dyslipidemia will be included if their concomitant pathology is well-controlled by treatment for at least one year
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- Normal vital signs after 10 minutes resting in supine position:
- 95 mmHg < systolic blood pressure (SBP) < 140 mmHg;
- 45 mmHg < diastolic blood pressure (DBP) < 90 mmHg;
- 40 bpm < heart rate < 100 bpm.
- Normal 12-lead electrocardiogram (ECG); 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 430 ms for male, 450 ms for female or not considered as clinically significant by the investigator
- Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; hepatic enzymes (aspartate amino-transferase or AST, alanine amino-transferase or ALT) should be strictly below the upper laboratory norm.
- Platelets ≥ 150 000 / mm3
- Mean corpuscular volume (MCV) and gamma glutamyl-transferase (GGT) should be strictly in the normal range of the laboratory
- Activated partial thromboplastin time (aPTT) ratio should be comprised between 0.95 and 1.15
- Estimated Creatinine clearance by Cockroft formula should be higher than 50 mL/min
- Non smoker or smoking the equivalent or less than 5 cigarettes a day and able not to smoke during the study hospitalization
- Normal gynecological examination no longer than 12 months before inclusion.
- For female with childbearing potential using an effective contraception method (e.g. intra-uterine device, hormonal contraception, diaphragm and condom) except if postmenopausal for more than 12 months or sterilized for more than three months
- Subject with coagulation test and blood count (including platelets) within the physiological ranges)
- Regulations:
- Having given written informed consent prior to any procedure related to the study
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research
- Not under any administrative or legal supervision
Who cannot join
- Medical history and clinical status:
- Contra-indication to anticoagulant therapy
- Subject with known increased bleeding time, hemophilia, thrombocytopenia, and/or history of any vascular purpura
- Subject with detectable antibody against heparin in the blood
- Any history or presence of clinically relevant cardiovascular, gynecologic (for women), pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease that is capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when taking the study medication; any acute infectious disease or signs of acute illness; except subject with hypertension, hypo- or hyperthyroidism or dyslipidemia if well-controlled by treatment for at least one year.
- Subject with diabetes or other cardiovascular or metabolic disease
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- Subject with INR > 1.5
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
- Blood donation or blood loss within one month before administration
- Symptomatic hypotension whatever the decrease in blood pressure or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day)
- Smoking more than 5 cigarettes or equivalent/day, or unable to stop smoking during the study
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses/day)
- Pregnancy (defined as positive beta-HCG plasma test that can not be explicated by menopauses), breast-feeding for female, any history or presence of clinically relevant gynecologic disease
- Interfering substance:
- Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, except for hormonal contraception or replacement therapy, and allowed therapy for stable pathology
- Anti-inflammatory treatments and anti-aggregant treatments are strictly forbidden during the whole study period
- General conditions:
- Subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development
- Subject in exclusion period of a previous study according to applicable regulations
- Subject who cannot be contacted in case of emergency
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol or any other protocol of the Investigating Center
- Subject is an employee of the Investigating Center
- Biological status:
- Positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV1 antibodies, anti-HIV2 antibodies, anti-LMWH antibodies
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids)
- Positive alcohol breath or plasma test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects
Primary objective:
- to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.
Secondary objective(s):
- to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
- to assess the tolerability of the different anticoagulation protocols
- Conditions
- Thrombosis
- Being tested
- Enoxaparin
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 4 hours following the last injection of enoxaparin Receives: Drug: Enoxaparin |
| B | Experimental | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 6 hours following the last injection of enoxaparin Receives: Drug: Enoxaparin |
| C | Experimental | 70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 10 hours following the last injection of enoxaparin Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration-time profiles of anti-Xa and anti-IIa levels
Measured: At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
Secondary outcomes (3)
Effect-time profiles of ACT, TGTppp and TGTprp
Measured: At baseline (Day 2) after the morning enoxaparin sc injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
PFA100 levels measured
Measured: At pre-dose, 4h and 14h post dose of enoxaparin
Documentation of adverse event, physical examination, clinical laboratory safety, vital signs and ECG recording at prespecified time-points.
Measured: during the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kazuki Otani, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622115
- Sponsor's protocol ID
- ENOXA_C_02537
- Other IDs
- 2007-000884-99
- Status last verified
- Mar 2011
- First submitted
- 13 Feb 2008
- Last updated
- 15 Mar 2011
- Results posted
- No
Publications
Drouet L, Bal dit Sollier C, Martin J. Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. Am Heart J. 2009 Aug;158(2):177-84. doi: 10.1016/j.ahj.2009.05.022.
PubMed 19619692
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00622115
- Acronym / sponsor ID
- ENOXA_C_02537
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Feb 2008 (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 characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.
Secondary objective(s):
- to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
- to assess the tolerability of the different anticoagulation protocols
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Enoxaparin70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 4 hours following the last injection of enoxaparin |
| B | Experimental | Drug: Enoxaparin70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 6 hours following the last injection of enoxaparin |
| C | Experimental | Drug: Enoxaparin70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 10 hours following the last injection of enoxaparin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Caucasian
- Male and female subjects, between 40 and 60 years of age
- Body weight between 50 kg and 90 kg if male and between 40 and 80 kg if female with Body Mass Index (BMI) between 18 and 29 kg/m2
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Subject with hypertension, hypo- or hyperthyroidism or dyslipidemia will be included if their concomitant pathology is well-controlled by treatment for at least one year
Key exclusion criteria (28 listed)
- Contra-indication to anticoagulant therapy
- Subject with known increased bleeding time, hemophilia, thrombocytopenia, and/or history of any vascular purpura
- Subject with detectable antibody against heparin in the blood
- Any history or presence of clinically relevant cardiovascular, gynecologic (for women), pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease that is capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when taking the study medication; any acute infectious disease or signs of acute illness; except subject with hypertension, hypo- or hyperthyroidism or dyslipidemia if well-controlled by treatment for at least one year.
- Subject with diabetes or other cardiovascular or metabolic disease
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 |
|---|---|---|
| Enoxaparin | Drug | A, B, C |
Primary outcome
Concentration-time profiles of anti-Xa and anti-IIa levels
Time frame: At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
3 secondary outcomes
Effect-time profiles of ACT, TGTppp and TGTprp
Time frame: At baseline (Day 2) after the morning enoxaparin sc injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
PFA100 levels measured
Time frame: At pre-dose, 4h and 14h post dose of enoxaparin
Documentation of adverse event, physical examination, clinical laboratory safety, vital signs and ECG recording at prespecified time-points.
Time frame: during the entire study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Background: PubMed 19619692Drouet L, Bal dit Sollier C, Martin J. Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. Am Heart J. 2009 Aug;158(2):177-84. doi: 10.1016/j.ahj.2009.05.022.
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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.
Kazuki Otani 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 1 study testing Enoxaparin in people with Thrombosis, run by Sanofi at 1 site in France.
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 24 inclusion and 28 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: finished, as of the sponsor's last update on 15 Mar 2011. 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration-time profiles of anti-Xa and anti-IIa levels (time frame: At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622115, which also lists 1 linked publication.
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 15 Mar 2011.