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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00311090




Registration number
NCT00311090
Ethics application status
Date submitted
4/04/2006
Date registered
5/04/2006
Date last updated
21/03/2016

Titles & IDs
Public title
Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
Scientific 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
Secondary ID [1] 0 0
2005-005326-30
Secondary ID [2] 0 0
EFC5945
Universal Trial Number (UTN)
Trial acronym
EQUINOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idrabiotaparinux sodium
Treatment: Drugs - Idraparinux sodium
Treatment: Drugs - Avidin
Treatment: Drugs - Placebo (for Avidin)

Experimental: Idrabiotaparinux - 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)

Active comparator: Idraparinux - 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)


Treatment: Drugs: Idrabiotaparinux sodium
0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Treatment: Drugs: Idraparinux sodium
0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Treatment: Drugs: Avidin
100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Treatment: Drugs: Placebo (for Avidin)
Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
Timepoint [1] 0 0
Day 183
Primary outcome [2] 0 0
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion
Timepoint [2] 0 0
Day 183 to Day 188
Secondary outcome [1] 0 0
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations
Timepoint [1] 0 0
Days 15, 36, 57, 92 and 183
Secondary outcome [2] 0 0
Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)
Timepoint [2] 0 0
First 6 months
Secondary outcome [3] 0 0
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC
Timepoint [3] 0 0
First 6 months

Eligibility
Key inclusion criteria
* Confirmed acute symptomatic DVT of the lower limbs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
757
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
NSW 2113 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Israel
State/province [10] 0 0
Natanya
Country [11] 0 0
Italy
State/province [11] 0 0
Milan
Country [12] 0 0
Mexico
State/province [12] 0 0
Mexico
Country [13] 0 0
Netherlands
State/province [13] 0 0
Gouda
Country [14] 0 0
New Zealand
State/province [14] 0 0
New Zealand
Country [15] 0 0
Poland
State/province [15] 0 0
Warsawa
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
South Africa
State/province [17] 0 0
Midrand
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/study/NCT00311090
Trial related presentations / 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.
Trellu 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.
Paty 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.
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00311090