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

February 19, 2016 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

757

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1642
        • Sanofi-Aventis
  • Australia
      • Macquarie Park, Australia, NSW 2113
        • Sanofi-Aventis
  • Austria
      • Vienna, Austria, 1220
        • Sanofi-Aventis
  • Belgium
      • Diegem, Belgium, 1831
        • Sanofi-Aventis
  • Brazil
      • Sao Paulo, Brazil, 05677-000
        • Sanofi-Aventis
  • Canada
      • Laval, Canada, H7L 4A8
        • Sanofi-Aventis
  • Czech Republic
      • Praha, Czech Republic, 160 00
        • Sanofi-Aventis
  • Denmark
      • Copenhagen, Denmark
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis France
  • Israel
      • Natanya, Israel
        • sanofi-aventis Israel
  • Italy
      • Milan, Italy
        • Sanofi-Aventis
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Mexico
  • Netherlands
      • Gouda, Netherlands
        • sanofi-aventis, Netherlands
  • New Zealand
      • New Zealand, New Zealand
        • Sanofi-Aventis
  • Poland
      • Warsawa, Poland, 02-672
        • Sanofi-Aventis
  • Russian Federation
      • Moscow, Russian Federation, 103045
        • Sanofi-Aventis
  • South Africa
      • Midrand, South Africa, 1685
        • Sanofi-Aventis
  • Spain
      • Barcelona, Spain, 08019
        • Sanofi-Aventis
  • Turkey
      • Istanbul, Turkey
        • Sanofi-aventis Turkey
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Other Names:
  • Biotinylated Idraparinux
  • SSR126517
Drug: Avidin

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Other Names:
  • SSR29261
Drug: Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes
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)
Drug: Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Drug: Idraparinux sodium

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Other Names:
  • SR34006

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
Time Frame: Day 183
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
Day 183 to Day 188

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations
Time Frame: Days 15, 36, 57, 92 and 183
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
First 6 months
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC
Time Frame: First 6 months
First 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 5, 2006

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5945
  • 2005-005326-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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