Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010080-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII, long acting | Drug | Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | after 1 and 2 weeks after dosing | |
| Frequency of serious adverse events | after 1, 2 and 6-10 weeks after dosing | |
| Frequency of MESIs (Medical Event of Special Interest) | after 1, 2 and 6-10 weeks after dosing | |
| Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa | after 2 and 6-10 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½ | from time of dosing up to 72 hours after the last dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrid | 28046 | Spain |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| activated recombinant human factor VII, long acting | Drug | Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours |
|
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
Not provided
Not provided