Approval Probability
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eptacog alfa · 7 trials · 10 indications
Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| vatreptacog alfa 5 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa 10 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa 20 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa 40 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa 80 mcg/kg | EXPERIMENTAL | - |
| rFVIIa 90 mcg/kg | EXPERIMENTAL | - |
| 270 microg/kg rFVIIa | ACTIVE_COMPARATOR | Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours |
| 3x90 microg/kg rFVIIa | ACTIVE_COMPARATOR | Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours |
| Pre-warfarin treatment (trial part A) | EXPERIMENTAL | - |
| Post-warfarin treatment (trial part B) | EXPERIMENTAL | - |
| Ex vivo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| eptacog alfa (activated) | DRUG | - |
| vatreptacog alfa (activated) | DRUG | 5 mcg/kg, injected i.v. |
| warfarin | DRUG | After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed |
| placebo | DRUG | If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration |
Inclusion Criteria: * Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: * Patients with secondary ICH * Pre-existing disability * Haemophilia
Eptacog alfa is used for haemostasis in congenital bleeding disorders, including haemophilia A and B with inhibitors, and acquired bleeding disorders. It is being investigated as a treatment to control bleeding episodes in these patient populations.
Eptacog alfa is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. Novo Nordisk is conducting clinical trials to evaluate the drug's efficacy and safety in bleeding disorders.
Eptacog alfa is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its ability to promote haemostasis in patients with congenital and acquired bleeding disorders.
Eptacog alfa has been studied in three completed clinical trials. NCT00486278 evaluated the drug in haemophilia patients with inhibitors for acute joint bleeds. NCT01561924 and NCT01561937 assessed its efficacy in congenital haemophilia and in reducing warfarin-induced bleeding, respectively. NCT01949792 investigated its pharmacokinetics.
Eptacog alfa is a recombinant activated factor VII that promotes haemostasis by activating the extrinsic coagulation pathway. It binds to tissue factor at sites of vascular injury, leading to the activation of factor X and the generation of thrombin, which helps form a stable blood clot.