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Also known as vatreptacog alfa (activated)
vatreptacog alfa · 2 trials · 4 indications
Any safety issue was reported as AE
Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody
| Arm | Type | Description |
|---|---|---|
| rFVIIa | EXPERIMENTAL | - |
| vatreptocog alfa | EXPERIMENTAL | - |
| vatreptacog alfa, 5 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa, 10 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa, 20 mcg/kg | EXPERIMENTAL | - |
| vatreptacog alfa, 30 mcg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| vatreptacog alfa (activated) | DRUG | 1-3 doses per bleeding episode |
| eptacog alfa (activated) | DRUG | 1-3 doses per bleeding episode |
| placebo | DRUG | Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg |
Inclusion Criteria: * Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX * Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry Exclusion Criteria: * Previous participation in t...
Vatreptacog alfa is an investigational therapy developed by Novo Nordisk A/S for congenital bleeding disorders, specifically congenital haemophilia with inhibitors. It was studied in a Phase 3 clinical trial in patients with haemophilia A or B who had developed inhibitors, and in a Phase 1 trial in healthy volunteers.
Vatreptacog alfa was being developed for the treatment of congenital bleeding disorders, specifically bleeding episodes in patients with congenital haemophilia A or B who have inhibitors. It has been studied in a Phase 3 trial in this patient population, but it is not described as an approved treatment.
Vatreptacog alfa is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk sponsored both clinical trials of the drug, including the Phase 3 study in patients with congenital haemophilia and inhibitors and the Phase 1 study in healthy volunteers.
Vatreptacog alfa has completed Phase 3 clinical development. Its Phase 3 trial, NCT01392547, and its Phase 1 trial, NCT00822185, are both listed as completed, and no trials are currently active. It is an investigational drug rather than a marketed product.
Vatreptacog alfa has been studied in two completed trials. NCT01392547 was a Phase 3 trial of 72 male patients aged 12 and older with congenital haemophilia and inhibitors, run across 19 countries. NCT00822185 was a Phase 1 safety, tolerability and pharmacokinetics trial of 32 healthy male volunteers in Japan.
Yes. Vatreptacog alfa (activated) is an alternative name for vatreptacog alfa, the same investigational compound developed by Novo Nordisk A/S for congenital bleeding disorders. Searches using either name refer to the same drug candidate and the same clinical trial program.