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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005326-30 | EudraCT Number |
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The three purposes of this study are the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idrabiotaparinux sodium | Drug | 0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20946157 | Result | 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. | |
| 23078631 | Derived | 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. |
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| Idraparinux sodium | Drug | 0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection |
|
|
| Avidin | Drug | 100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes |
|
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| Placebo (for Avidin) | Drug | Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes |
|
| First 6 months |
| Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC | First 6 months |
| Buenos Aires |
| 1642 |
| Argentina |
| Sanofi-Aventis | Macquarie Park | NSW 2113 | Australia |
| Sanofi-Aventis | Vienna | 1220 | Austria |
| Sanofi-Aventis | Diegem | 1831 | Belgium |
| Sanofi-Aventis | São Paulo | 05677-000 | Brazil |
| Sanofi-Aventis | Laval | H7L 4A8 | Canada |
| Sanofi-Aventis | Prague | 160 00 | Czechia |
| Sanofi-Aventis | Copenhagen | Denmark |
| sanofi-aventis France | Paris | France |
| sanofi-aventis Israel | Netanya | Israel |
| Sanofi-aventis | Milan | Italy |
| sanofi-aventis Mexico | México | Mexico |
| sanofi-aventis, Netherlands | Gouda | Netherlands |
| Sanofi-Aventis | New Zealand | New Zealand |
| Sanofi-Aventis | Warsaw | 02-672 | Poland |
| Sanofi-aventis | Moscow | 103045 | Russia |
| Sanofi-Aventis | Midrand | 1685 | South Africa |
| Sanofi-Aventis | Barcelona | 08019 | Spain |
| sanofi-aventis Turkey | Istanbul | Turkey (Türkiye) |
| 20088937 | 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. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C479958 | idraparinux |
| D001360 | Avidin |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010047 | Ovalbumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015387 | Egg Proteins, Dietary |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D004527 | Egg Proteins |
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