Approval Probability
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Adjusted LOA
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Idrabiotaparinux · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Idrabiotaparinux | EXPERIMENTAL | Idrabiotaparinux sodium, 3.0 mg, once-weekly for 3 or 6 months depending on the stratum, after enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage). |
| Warfarin | ACTIVE_COMPARATOR | Warfarin, INR-adjusted dose, started 24 hours after the start of enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days, and continued for 3 or 6 months depending on the stratum. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage). |
| 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 |
|---|---|---|
| Idrabiotaparinux sodium | DRUG | 0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection |
| Warfarin | DRUG | Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration |
| Placebo (for idrabiotaparinux sodium) | DRUG | 0.5 mL pre-filled syringe Subcutaneous injection |
| Avidin | DRUG | 100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes |
| Placebo (for warfarin) | DRUG | Warfarin matching capsules Oral administration |
| Enoxaparin | DRUG | Prefilled syringes as locally registered Subcutaneous injection |
| Idraparinux sodium | DRUG | 0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection |
| Placebo (for Avidin) | DRUG | Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes |
Inclusion Criteria: * Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis Exclusion Criteria: * End stage renal failure, hepatic failure, uncontrolled hypertension; * Active bleeding or high risk for bleeding; * Pregnancy or childbearing potential without proper contra...
Idrabiotaparinux is an investigational small molecule being developed for the treatment of deep venous thrombosis and pulmonary embolism. It has been studied in Phase 3 clinical trials for these cardiovascular conditions.
Idrabiotaparinux is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for the treatment of deep venous thrombosis and embolism.
Idrabiotaparinux is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Clinical trials have been completed to evaluate its use in patients with deep venous thrombosis and pulmonary embolism.
Idrabiotaparinux has been studied in two completed Phase 3 clinical trials. One trial, NCT00311090, enrolled 757 patients with deep venous thrombosis of the lower limbs. Another trial, NCT00345618, enrolled 3202 patients with pulmonary embolism and thrombosis.
Idrabiotaparinux is related to Idraparinux, as one clinical trial was designed to assess the bioequipotency of the two drugs. The trial compared Idrabiotaparinux and Idraparinux in patients with deep venous thrombosis to evaluate their relative effects.