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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Idrabiotaparinux sodium

Intervention Type DRUG

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Avidin

Intervention Type DRUG

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Placebo (for Avidin)

Intervention Type DRUG

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

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)

Group Type ACTIVE_COMPARATOR

Idraparinux sodium

Intervention Type DRUG

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Placebo (for Avidin)

Intervention Type DRUG

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Interventions

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Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Intervention Type DRUG

Idraparinux sodium

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Intervention Type DRUG

Avidin

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Intervention Type DRUG

Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Intervention Type DRUG

Other Intervention Names

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Biotinylated Idraparinux SSR126517 SR34006 SSR29261

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis

Macquarie Park, , Australia

Site Status

Sanofi-Aventis

Vienna, , Austria

Site Status

Sanofi-Aventis

Diegem, , Belgium

Site Status

Sanofi-Aventis

São Paulo, , Brazil

Site Status

Sanofi-Aventis

Laval, , Canada

Site Status

Sanofi-Aventis

Prague, , Czechia

Site Status

Sanofi-Aventis

Copenhagen, , Denmark

Site Status

sanofi-aventis France

Paris, , France

Site Status

sanofi-aventis Israel

Netanya, , Israel

Site Status

Sanofi-aventis

Milan, , Italy

Site Status

sanofi-aventis Mexico

México, , Mexico

Site Status

sanofi-aventis, Netherlands

Gouda, , Netherlands

Site Status

Sanofi-Aventis

New Zealand, , New Zealand

Site Status

Sanofi-Aventis

Warsaw, , Poland

Site Status

Sanofi-aventis

Moscow, , Russia

Site Status

Sanofi-Aventis

Midrand, , South Africa

Site Status

Sanofi-Aventis

Barcelona, , Spain

Site Status

sanofi-aventis Turkey

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Czechia Denmark France Israel Italy Mexico Netherlands New Zealand Poland Russia South Africa Spain Turkey (Türkiye)