Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311090

Acronym

EQUINOX

Enrollment

757

Registered

2006-04-05

Start date

2006-04-30

Completion date

2008-01-31

Last updated

2016-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

Deep Venous Thrombosis

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.

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.

Interventions

DRUGIdrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection

DRUGIdraparinux sodium

0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection

DRUGAvidin

100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes

DRUGPlacebo (for Avidin)

Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed acute symptomatic DVT of the lower limbs

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.

Design outcomes

Primary

Measure	Time frame
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters	Day 183
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion	Day 183 to Day 188

Secondary

Measure	Time frame
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations	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)	First 6 months
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC	First 6 months

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Russia, South Africa, Spain, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026