Skip to main content
OpenTrials
Completed

NCT Number: NCT00311090

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Idrabiotaparinux sodium

Drug

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Other names: Biotinylated Idraparinux, SSR126517

Idraparinux sodium

Drug

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Other names: SR34006

Avidin

Drug

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Other names: SSR29261

Placebo (for Avidin)

Drug

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Primary outcomes

  1. Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters

    Time frame: Day 183

  2. 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

Secondary outcomes

  1. Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations

    Time frame: Days 15, 36, 57, 92 and 183

  2. 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

  3. Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC

    Time frame: First 6 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: EQUINOX

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2006
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.