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

NCT00311090 | Completed Phase 3 DMC

• 2 other identifiers: EFC59452005-005326-30
• Study Type: interventional
• Target: 757
• Locations: 19 countries
• Sites: 19

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.

Conditions

Deep Venous Thrombosis

Keywords

Deep Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

• Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters

  Day 183

• Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion

  Day 183 to Day 188

Secondary Outcomes (3)

• Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations

  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)

  First 6 months

• Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC

  First 6 months

Study Arms (2)

Idrabiotaparinux

EXPERIMENTAL

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; Drug: Avidin; Drug: Placebo (for Avidin)

Idraparinux

ACTIVE COMPARATOR

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; Drug: Placebo (for Avidin)

Interventions

Idrabiotaparinux sodium DRUG

0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection

Also known as: Biotinylated Idraparinux, SSR126517

Idrabiotaparinux

Idraparinux sodium DRUG

0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection

Also known as: SR34006

Idraparinux

Avidin DRUG

100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes

Also known as: SSR29261

Idrabiotaparinux

Placebo (for Avidin) DRUG

Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes

Idrabiotaparinux; Idraparinux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed acute symptomatic DVT of the lower limbs

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (20)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Buenos Aires, 1642, Argentina

Location

Sanofi-Aventis

Macquarie Park, NSW 2113, Australia

Location

Sanofi-Aventis

Vienna, 1220, Austria

Location

Sanofi-Aventis

Diegem, 1831, Belgium

Location

Sanofi-Aventis

São Paulo, 05677-000, Brazil

Location

Sanofi-Aventis

Laval, H7L 4A8, Canada

Location

Sanofi-Aventis

Prague, 160 00, Czechia

Location

Sanofi-Aventis

Copenhagen, Denmark

Location

sanofi-aventis France

Paris, France

Location

sanofi-aventis Israel

Netanya, Israel

Location

Sanofi-aventis

Milan, Italy

Location

sanofi-aventis Mexico

México, Mexico

Location

sanofi-aventis, Netherlands

Gouda, Netherlands

Location

Sanofi-Aventis

New Zealand, New Zealand

Location

Sanofi-Aventis

Warsaw, 02-672, Poland

Location

Sanofi-aventis

Moscow, 103045, Russia

Location

Sanofi-Aventis

Midrand, 1685, South Africa

Location

Sanofi-Aventis

Barcelona, 08019, Spain

Location

sanofi-aventis Turkey

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 20946157 RESULT

• 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.

  PMID: 23078631 DERIVED

• 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.

  PMID: 20088937 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

idraparinux; Avidin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Ovalbumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Egg Proteins, Dietary; Animal Proteins, Dietary; Dietary Proteins; Egg Proteins

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 5, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 21, 2016

Record last verified: 2016-02

Locations

AR (1); CZ (1); FR (1); NZ (1); BE (1); DK (1); BR (1); IT (1); PL (1); ZA (1); AU (1); CA (1); ES (1); TU (1); IL (1); RU (1); NL (1); ME (1); US (1)