Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nadroparin · 2 trials · 1 indication
VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).
| Arm | Type | Description |
|---|---|---|
| Nadroparin | ACTIVE_COMPARATOR | After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal. |
| Fondaparinux | EXPERIMENTAL | After randomization (Day 1), subjects will receive subcutaneously, once daily, fondaparinux 2.5 mg (1.5 mg in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal. |
| No Nadroparin | NO_INTERVENTION | Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin |
| Name | Type | Description |
|---|---|---|
| Fondaparinux sodium | DRUG | After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg \[0.5mL\] (1.5 mg \[0.3mL\] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. |
| Nadroparin | DRUG | After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. |
Inclusion Criteria: * Requiring rigid or semi-rigid immobilization (e.g. with a plaster cast or brace) for at least 21 days and up to 45 days because of isolated non-surgical below-knee injury * With a no weight-bearing recommendation at the time of inclusion (partial weight bearing is permitted e....
Nadroparin is used for the treatment and prevention of venous thrombosis, a condition involving blood clots in the veins. It is a small molecule developed by GSK plc and has been studied in Phase 3 clinical trials for this indication.
Nadroparin works by targeting and activating SERINC1, also known as antithrombin III. This activation enhances the inhibition of clotting factors, thereby reducing blood clot formation. It is classified as an activator of SERINC1.
Nadroparin is being developed by GSK plc, which trades under the ticker symbol GSK. GSK is a global pharmaceutical company involved in the research and development of various therapeutic products.
Nadroparin is in Phase 3 of clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 3 trials have been completed.
Nadroparin has been studied in two completed Phase 3 clinical trials: NCT00843492, which evaluated fondaparinux for venous blood clot prevention in patients with below-knee injuries, and NCT00312013, which investigated nadroparin in patients with lung, pancreas, or prostate cancer. Both trials are completed.