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Also known as eptacog alfa (activated)
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 to treat bleeding and support haemostasis in people with acquired or congenital bleeding disorders. Its studied uses include haemophilia A and haemophilia B, including patients with inhibitors, and reducing bleeding caused by warfarin treatment. It is being developed by Novo Nordisk A/S.
Eptacog alfa targets coagulation factor VII, also known as F7. It is an exogenous protein, meaning it supplies activated factor VII from outside the body. By acting at this step of the clotting cascade, it is intended to promote clot formation and control bleeding in patients with bleeding disorders.
Eptacog alfa is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is listed as the developer of the asset, which is being studied in hematology for acquired and congenital bleeding disorders and for haemostasis.
Eptacog alfa is in Phase 3 development and is investigational. It has not been approved based on the information available. Three completed trials are recorded, with no active trials at present, and the program has enrolled 969 patients overall.
Completed studies include NCT01949792, a Phase 1 pharmacokinetic and pharmacodynamic trial in haemophilia A or B with or without inhibitors; NCT01561937, a Phase 1 trial on reducing warfarin-related bleeding; NCT01561924, a Phase 1 thromboelastography study; and NCT00486278, a Phase 2 trial in haemophilia patients with inhibitors treated for acute joint bleeds.
Yes, eptacog alfa (activated) is another name for eptacog alfa. Both names refer to the same Novo Nordisk A/S product, so searches using either term lead to the same asset in Phase 3 development for bleeding disorders and haemostasis.