Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being developed for congenital bleeding disorders, specifically for patients with congenital haemophilia A with inhibitors and haemophilia B with inhibitors. It is a small molecule being studied in a Phase 3 clinical trial to evaluate its efficacy and safety in this patient population.
Vatreptacog alfa is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating congenital bleeding disorders.
Vatreptacog alfa is currently in Phase 3 clinical development. It has completed two clinical trials, including a Phase 1 study in healthy volunteers and a Phase 3 efficacy and safety study in patients with congenital haemophilia and inhibitors. The drug remains investigational and has not been approved.
Vatreptacog alfa has been studied in two completed clinical trials. The Phase 1 trial (NCT00822185) assessed safety, tolerability, and pharmacokinetics in healthy volunteers in Japan. The Phase 3 trial (NCT01392547) evaluated efficacy and safety in male patients aged 12 years and older with congenital haemophilia and inhibitors across multiple countries.
Vatreptacog alfa is also known as NN1731 and NNC 0078-0000-0007. The Phase 1 trial referenced the drug as NN1731, while the Phase 3 trial used the name NNC 0078-0000-0007. These names refer to the same investigational compound being developed by Novo Nordisk.