CompletedPhase 3

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

United States, Argentina, Australia757 participantsStarted 2006-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 183

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

Timeframe: Day 183 to Day 188

Trial details

NCT IDNCT00311090

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

View on ClinicalTrials.gov More Deep Venous Thrombosis trials