Deep Venous ThrombosisPhase 3EQUINOXNCT00311090
Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
A Phase 3 study testing Idrabiotaparinux sodium, Idraparinux sodium and Avidin in people with Deep Venous Thrombosis, run by Sanofi at 20 sites in 20 countries.
Trial summary
The three purposes of this study are the following: To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk; To compare the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Idrabiotaparinux sodium, Idraparinux sodium and Avidin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 757 participants
- Where
- 20 sitesin 20 countries
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed acute symptomatic DVT of the lower limbs
Who cannot join
- Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
- Active bleeding or high risk for bleeding.
- Pregnancy or childbearing potential without proper contraceptive measures.
- Breastfeeding
- Known allergy to idraparinux, SSR126517E, or egg proteins
- Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
- Symptomatic pulmonary embolism (PE)
- Life expectancy < 6 months.
Trial locations and contacts
20 sites in 20 countries.
20 sites in 20 countries
About this study
Official title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
The three purposes of this study are the following:
- To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
- To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
- To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.
Read the detailed description
The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12.
All participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Idrabiotaparinux sodium, Idraparinux sodium, Avidin, Placebo (for Avidin)
- Keywords
- Deep Venous Thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idrabiotaparinux sodiumDrug
Also called Biotinylated Idraparinux, SSR126517
0.5 mL pre-filled syringe for 3.0 mg
Subcutaneous injection
Idraparinux sodiumDrug
Also called SR34006
0.5 mL pre-filled syringe for 2.5 mg
Subcutaneous injection
AvidinDrug
Also called SSR29261
100 mg in 10 mg/mL solution
Intravenous infusion for 30 minutes
Placebo (for Avidin)Drug
Avidin matching powder in 10 mg/mL solution
Intravenous infusion for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Idrabiotaparinux | Experimental | Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months.
In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration) Receives: Drug: Idrabiotaparinux sodium; Drug: Avidin; Drug: Placebo (for Avidin) |
| Idraparinux | Active comparator | Idraparinux sodium, 2.5 mg, once-weekly for 6 months
In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration) Receives: Drug: Idraparinux sodium; Drug: Placebo (for Avidin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
Measured: Day 183
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion
Measured: Day 183 to Day 188
Secondary outcomes (3)
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations
Measured: Days 15, 36, 57, 92 and 183
Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)
Measured: First 6 months
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC
Measured: First 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Venous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311090
- Sponsor's protocol ID
- EFC5945
- Other IDs
- 2005-005326-30, 2005
- Acronym
- EQUINOX
- Status last verified
- Feb 2016
- First submitted
- 4 Apr 2006
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost. 2011 Jan;9(1):92-9. doi: 10.1111/j.1538-7836.2010.04100.x.
PubMed 20946157Trellu M, Fau JB, Cortez P, Cheng S, Paty I, Boelle E, Donat F, Sanderink GJ. Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis. Br J Clin Pharmacol. 2013 May;75(5):1255-64. doi: 10.1111/bcp.12009.
PubMed 23078631Paty I, Trellu M, Destors JM, Cortez P, Boelle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost. 2010 Apr;8(4):722-9. doi: 10.1111/j.1538-7836.2010.03746.x. Epub 2010 Jan 17.
PubMed 20088937
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
- ClinicalTrials.gov ID
- NCT00311090
- Acronym / sponsor ID
- EQUINOX / EFC5945
- Conditions
- Deep Venous Thrombosis
- Keywords
- Deep Venous Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Apr 2006 (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.
The three purposes of this study are the following:
- To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
- To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
- To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.
Detailed description
The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12.
All participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idrabiotaparinux | Experimental | Drug: Idrabiotaparinux sodium, Drug: Avidin, Drug: Placebo (for Avidin)Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months. In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration) |
| Idraparinux | Active comparator | Drug: Idraparinux sodium, Drug: Placebo (for Avidin)Idraparinux sodium, 2.5 mg, once-weekly for 6 months In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed acute symptomatic DVT of the lower limbs
Key exclusion criteria (8 listed)
- Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
- Active bleeding or high risk for bleeding.
- Pregnancy or childbearing potential without proper contraceptive measures.
- Breastfeeding
- Known allergy to idraparinux, SSR126517E, or egg proteins
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 |
|---|---|---|
| Idrabiotaparinux sodiumAlso: Biotinylated Idraparinux, SSR1265170.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection | Drug | Idrabiotaparinux |
| Idraparinux sodiumAlso: SR340060.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection | Drug | Idraparinux |
| AvidinAlso: SSR29261100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes | Drug | Idrabiotaparinux |
| Placebo (for Avidin)Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes | Drug | Idrabiotaparinux, Idraparinux |
Primary outcome
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
Time frame: Day 183
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion
Time frame: Day 183 to Day 188
3 secondary outcomes
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations
Time frame: Days 15, 36, 57, 92 and 183
Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)
Time frame: First 6 months
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC
Time frame: First 6 months
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 21 Mar 2016.
- Results publication: PubMed 20946157Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost. 2011 Jan;9(1):92-9. doi: 10.1111/j.1538-7836.2010.04100.x.
- Derived from this study: PubMed 23078631Trellu M, Fau JB, Cortez P, Cheng S, Paty I, Boelle E, Donat F, Sanderink GJ. Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis. Br J Clin Pharmacol. 2013 May;75(5):1255-64. doi: 10.1111/bcp.12009.
- Derived from this study: PubMed 20088937Paty I, Trellu M, Destors JM, Cortez P, Boelle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost. 2010 Apr;8(4):722-9. doi: 10.1111/j.1538-7836.2010.03746.x. Epub 2010 Jan 17.
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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.
ICD CSD study director
Sanofi
20 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Idrabiotaparinux sodium, Idraparinux sodium and Avidin in people with Deep Venous Thrombosis, run by Sanofi at 20 sites in 20 countries.
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 1 inclusion and 8 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 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Argentina, Australia, Austria, Belgium and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (time frame: Day 183). 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?
On the ClinicalTrials.gov record for NCT00311090, which also lists 3 linked publications.
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 21 Mar 2016.