Bioequipotency Study of SSR126517E and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs

Deep Venous Thrombosis Clinical Trial

— EQUINOX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311090
• Other study ID #: EFC5945
• Secondary ID: 2005-005326-30
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2006
• Last updated: November 27, 2013
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSouth Africa: Medicines Control CouncilRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Idrabiotaparinux
0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection
• Idraparinux
0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection
• Avidin
100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes
• Placebo (for Avidin)
Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Australia	Sanofi-Aventis	Macquarie Park
Austria	Sanofi-Aventis	Vienna
Belgium	Sanofi-Aventis	Diegem
Brazil	Sanofi-Aventis	Sao Paulo
Canada	Sanofi-Aventis	Laval
Czech Republic	Sanofi-Aventis	Praha
Denmark	Sanofi-Aventis	Copenhagen
France	sanofi-aventis France	Paris
Israel	sanofi-aventis Israel	Natanya
Italy	Sanofi-aventis	Milan
Mexico	sanofi-aventis Mexico	Mexico
Netherlands	sanofi-aventis, Netherlands	Gouda
New Zealand	Sanofi-Aventis	New Zealand
Poland	Sanofi-Aventis	Warsawa
Russian Federation	Sanofi-aventis	Moscow
South Africa	Sanofi-Aventis	Midrand
Spain	Sanofi-Aventis	Barcelona
Turkey	sanofi-aventis Turkey	Istanbul
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Israel,  Italy,  Mexico,  Netherlands,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain,  Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters		Day 183	No
Primary	Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion		Day 183 to Day 188	No
Secondary	Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations		Days 15, 36, 57, 92 and 183	No
Secondary	Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)		First 6 months	Yes
Secondary	Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC		First 6 months	No