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. - EQUINOX

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005326-30-AT

Enrollment

700

Registered

2006-02-21

Start date

2006-05-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with confirmed acute symptomatic DVT of the lower limbs MedDRA version: 8.1 Level: PT Classification code 10051055

Interventions

Product Name: Idraparinux Product Code: SR34006 Pharmaceutical Form: Solution for injection INN or Proposed INN: Idraparinux sodium CAS Number: 149920-56-9 Current Sponsor code: SR34006 Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Confirmed acute symptomatic DVT of the lower limbs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1-Exclusion criteria before initial randomization: Legal lower age limitations (country specific). Creatinine clearance 180 mm Hg or diastolic blood pressure > 110 mm Hg. Pregnancy or childbearing potential without proper contraceptive measures. Breastfeeding. Known allergy to idraparinux, SSR126517E, or egg proteins. -Criteria related to study methodology Written informed consent not signed. Indication of prolonged anticoagulation for other reason than DVT of the lower limbs. Symtomatic pulmonary embolism (PE). Any administration or intended use of a fibrinolytic agent, thrombectomy, insertion of a caval filter, to treat the current episode of DVT. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) Heparin, fondaparinux or initiation of VKA treatment prior to randomization Life expectancy < 6 months. Participation in another pharmacotherapeutic study within the prior 30 days. Impossibility to meet protocol requirements. 2-Exclusion criteria at the end of the 6-month treatment period for participation in the avidin neutralizing effect assessment Patient receiving open-label avidin during the study. Patient requiring more than 6-month anticoagulant treatment.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To assess the time course to steady state achievement of SSR126517E/SR34006. To provide safety and efficacy data on biotinylated idraparinux (SSR126517E) compared to idraparinux (SR34006).;Main Objective: -Primary objective of the bioequipotency assessment: To demonstrate the bioequipotency of biotinylated idraparinux (SSR126517E) and idraparinux (SR34006) at steady state, in patients, with acute symptomatic DVT, as assessed by anti-Xa activity. -Primary objective of the avidin neutralizing effect assessment: To demonstrate the neutralizing effect of avidin (SSR29261) on anti-Xa activity induced by biotinylated idraparinux (SSR126517E).;Primary end point(s): PRIMARY ENDPOINTS AND MAIN SECONDARY ENDPOINTS: 1-Bioequipotency assessment, avidin neutralizing effect assessment and time course to steady state achievement The PD variable is the anti-Xa activity, measured without excess of antithrombin (AT), relative to the maximal effect in a pool of plasma from healthy volunteers. The PK variable is the anti-Xa activity, measured with excess of AT. 2-Safety assessment The main two-safety outcome events are bleeding, reported as either AE or SAE, and validated by the CIAC, and death (cause of death validated by the CIAC). 3-Efficacy assessment The main efficacy outcome is symptomatic recurrent DVT/PE (fatal or not), as validated by the CIAC.	—

Measure

Time frame

Secondary Objective: To assess the time course to steady state achievement of SSR126517E/SR34006. To provide safety and efficacy data on biotinylated idraparinux (SSR126517E) compared to idraparinux (SR34006).;Main Objective: -Primary objective of the bioequipotency assessment: To demonstrate the bioequipotency of biotinylated idraparinux (SSR126517E) and idraparinux (SR34006) at steady state, in patients, with acute symptomatic DVT, as assessed by anti-Xa activity. -Primary objective of the avidin neutralizing effect assessment: To demonstrate the neutralizing effect of avidin (SSR29261) on anti-Xa activity induced by biotinylated idraparinux (SSR126517E).;Primary end point(s): PRIMARY ENDPOINTS AND MAIN SECONDARY ENDPOINTS: 1-Bioequipotency assessment, avidin neutralizing effect assessment and time course to steady state achievement The PD variable is the anti-Xa activity, measured without excess of antithrombin (AT), relative to the maximal effect in a pool of plasma from healthy volunteers. The PK variable is the anti-Xa activity, measured with excess of AT. 2-Safety assessment The main two-safety outcome events are bleeding, reported as either AE or SAE, and validated by the CIAC, and death (cause of death validated by the CIAC). 3-Efficacy assessment The main efficacy outcome is symptomatic recurrent DVT/PE (fatal or not), as validated by the CIAC.

—

Countries

Austria, Czech Republic, Denmark, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026