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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00311090
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 4, 2006
First Posted Date  ICMJE April 5, 2006
Last Update Posted Date March 21, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2006)
  • Bioequipotency assessment and avidin neutralizing effect assessment, at steady state:
  • The pharmacodynamic/pharmacokinetic variable is the antithrombotic activity (anti-Xa activity)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2006)
  • PK/PD: time course to steady state achievement(anti-Xa activity)
  • Safety:bleeding adverse events and deaths within 6 months validated by the Central Independent Adjudication Committee (CIAC).
  • Efficacy:symptomatic recurrent DVT/PE (fatal or not) within 6 months validated by the CIAC.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Deep Venous Thrombosis
Intervention  ICMJE
  • Drug: Idrabiotaparinux sodium

    0.5 mL pre-filled syringe for 3.0 mg

    Subcutaneous injection

    Other Names:
    • Biotinylated Idraparinux
    • SSR126517
  • Drug: Idraparinux sodium

    0.5 mL pre-filled syringe for 2.5 mg

    Subcutaneous injection

    Other Name: SR34006
  • Drug: Avidin

    100 mg in 10 mg/mL solution

    Intravenous infusion for 30 minutes

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

    Avidin matching powder in 10 mg/mL solution

    Intravenous infusion for 30 minutes

Study Arms  ICMJE
  • 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)

    Interventions:
    • Drug: Idrabiotaparinux sodium
    • Drug: Avidin
    • Drug: Placebo (for Avidin)
  • 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)

    Interventions:
    • Drug: Idraparinux sodium
    • Drug: Placebo (for Avidin)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2010)
757
Original Enrollment  ICMJE
 (submitted: April 4, 2006)
700
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries Germany,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT00311090
Other Study ID Numbers  ICMJE EFC5945
2005-005326-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP