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

• ClinicalTrials.gov Identifier: NCT00311090
• Recruitment Status: Completed
• First Posted: April 5, 2006
• Last Update Posted: March 21, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Deep Venous Thrombosis	Drug: Idrabiotaparinux sodium; Drug: Idraparinux sodium; Drug: Avidin; Drug: Placebo (for Avidin)	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 757 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: April 2006
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

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 Name: 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: Idraparinux sodium; 0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection; Other Name: SR34006; Drug: Placebo (for Avidin); Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New Jersey

Sanofi-Aventis

Bridgewater, New Jersey, United States, 08807

Argentina

Sanofi-Aventis

Buenos Aires, Argentina, 1642

Australia

Sanofi-Aventis

Macquarie Park, Australia, NSW 2113

Austria

Sanofi-Aventis

Vienna, Austria, 1220

Belgium

Sanofi-Aventis

Diegem, Belgium, 1831

Brazil

Sanofi-Aventis

Sao Paulo, Brazil, 05677-000

Canada

Sanofi-Aventis

Laval, Canada, H7L 4A8

Czech Republic

Sanofi-Aventis

Praha, Czech Republic, 160 00

Denmark

Sanofi-Aventis

Copenhagen, Denmark

France

sanofi-aventis France

Paris, France

Israel

sanofi-aventis Israel

Natanya, Israel

Italy

Sanofi-aventis

Milan, Italy

Mexico

sanofi-aventis Mexico

Mexico, Mexico

Netherlands

sanofi-aventis, Netherlands

Gouda, Netherlands

New Zealand

Sanofi-Aventis

New Zealand, New Zealand

Poland

Sanofi-Aventis

Warsawa, Poland, 02-672

Russian Federation

Sanofi-aventis

Moscow, Russian Federation, 103045

South Africa

Sanofi-Aventis

Midrand, South Africa, 1685

Spain

Sanofi-Aventis

Barcelona, Spain, 08019

Turkey

sanofi-aventis Turkey

Istanbul, Turkey

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: ICD CSD; Sanofi

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00311090
• Other Study ID Numbers: EFC5945; 2005-005326-30 ( EudraCT Number )
• First Posted: April 5, 2006
• Last Update Posted: March 21, 2016
• Last Verified: February 2016

Keywords provided by Sanofi:

Deep Venous Thrombosis

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Idraparinux; Idrabiotaparinux; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants