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Also known as activated recombinant human factor VII
activated recombinant human factor VII, long acting · 22 trials · 18 indications
| Arm | Type | Description |
|---|---|---|
| Activated recombinant human factor VII | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Factor VII | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | - |
| Low dose | EXPERIMENTAL | - |
| rFVIIa | EXPERIMENTAL | - |
| Medium dose | EXPERIMENTAL | - |
| CP-rFVIIa | ACTIVE_COMPARATOR | - |
| VII25 | EXPERIMENTAL | - |
| Adults | EXPERIMENTAL | - |
| Paediatric | EXPERIMENTAL | - |
| Treatment sequence 1 | EXPERIMENTAL | - |
| Treatment sequence 2 | EXPERIMENTAL | - |
| Treatment sequence 3 | EXPERIMENTAL | - |
| Treatment sequence 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| activated recombinant human factor VII | DRUG | Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered |
| placebo | DRUG | Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered |
| activated recombinant human factor VII, long acting | DRUG | After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months |
| standard therapy | PROCEDURE | Standard treatment of bleeding |
Inclusion Criteria: * Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject * Children with complex congenital heart disease requiring ...
Activated recombinant human factor VII, long acting is an investigational therapy developed by Novo Nordisk A/S for bleeding disorders. It is being studied in acquired bleeding disorder, congenital bleeding disorder, and other haemostasis disorders. It is a long-acting form of activated recombinant human factor VII, designed to support clot formation in patients experiencing bleeding.
Activated recombinant human factor VII, long acting is being developed to treat acquired bleeding disorders, congenital bleeding disorders, and other haemostasis disorders. Clinical studies have evaluated it in bleeding related to dengue haemorrhagic fever, trauma, pelvic-acetabular fracture reconstruction, and acute intracerebral haemorrhage. It is intended to help control bleeding in these settings.
Activated recombinant human factor VII, long acting targets coagulation factor V (F5) and coagulation factor VIII (F8). It belongs to the inhibitor class. By acting on these coagulation factors, it is intended to promote haemostasis and support blood clotting in patients with bleeding disorders or acquired bleeding complications.
Novo Nordisk A/S is developing activated recombinant human factor VII, long acting. Novo Nordisk trades on the New York Stock Exchange under the ticker NVO. The company is responsible for the clinical development program, which includes completed Phase 2 and Phase 3 studies in bleeding and haemostasis disorders.
Activated recombinant human factor VII, long acting is in Phase 3 development. It is investigational and has not been approved by the FDA. Thirteen clinical trials have been completed, with no active trials currently listed. The program includes randomized, double-blind, active-controlled studies across multiple bleeding and haemostasis indications.
Completed trials include NCT01601613 in dengue haemorrhagic fever, NCT01601457 in pelvic-acetabular fracture reconstruction, NCT01566786 in acute intracerebral haemorrhage, and NCT01563523 in severely injured trauma patients. These Phase 2 studies enrolled patients across multiple countries. Overall, thirteen trials have been completed, with total enrollment of 1,861 participants.
Yes, activated recombinant human factor VII, long acting is also known as activated recombinant human factor VII. The long-acting designation refers to the extended-duration formulation of the same agent. Both names refer to the Novo Nordisk A/S product candidate being studied in bleeding and haemostasis disorders.