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This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.
Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FVII |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable | Evaluated at 6 hours | |
| Treatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable | Evaluated after 30 days | |
| Treatment of bleeding episodes at clinic/hospital: Time to achieve arrest of bleeding | Time to achieve arrest of bleeding | |
| Treatment of bleeding episodes at clinic/hospital: Number of re-bleeding episodes | Within 5 days after first product administration | |
| Treatment of bleeding episodes at home: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable | Evaluated at 6 hours | |
| Treatment of bleeding episodes at home: Time to achieve arrest of bleeding | Time to achieve arrest of bleeding | |
| Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective | After surgery | |
| Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective | Evaluated after 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bleeding episodes during prophylaxis per year | Up to one year | |
| Number of intensive care unit (ICU) and/or the number of ward days | After first haemostatic product administration until day 30 |
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Inclusion Criteria:
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Patients with FVII deficiency (levels of FVII less than 50% of normal or a mutation known to be associated to a FVII deficiency) can be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Princeton | New Jersey | 08540 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21158750 | Result | Mariani G, Dolce A, Batorova A, Auerswald G, Schved JF, Siragusa S, Napolitano M, Knudsen JB, Ingerslev J; STER and the International Factor VII Deficiency Study Groups. Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER. Br J Haematol. 2011 Feb;152(3):340-6. doi: 10.1111/j.1365-2141.2010.08287.x. Epub 2010 Dec 16. | |
| 22356641 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Plasma for assaying of inhibiting antibodies to FVII. All samples, which are analysed at the local hospital laboratory, are to be stored and destroyed according to local rules. Inhibitor samples analysed at the central laboratory will be stored until data validation has taken place at the end of the study after which the samples will be destroyed.
| Fresh frozen plasma (Source unspecified) | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Plasma-derived FVII (LFB) | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Prothrombin Complex conc. (PCC) | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Plasma-derived FVII conc. (pdFVII Baxter) | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Plasma-derived FVII conc. (pdFVII PFL) | Drug | Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator. |
|
| Estimated blood loss volume | During surgery/delivery |
| Number of red blood cell units administered | During surgery |
| Number of days spent in hospital | Until last data collection (20 Jan 2012) |
| Number of re-bleeding episodes (associated with the surgery) | Within 5 days after surgery |
| Prophylactic treatment efficacy evaluation: excellent, excellent, partially effective, or effective | 30 days after first prophylaxis dose |
| Mortality | Within a 30-day (follow-up) period |
| Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) | Prior to dosing |
| Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) | After 15 minutes |
| Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) | After 30 days |
| Presence of and/or de novo appearance of inhibiting antibodies to FVII | Prior to dosing |
| Presence of and/or de novo appearance of inhibiting antibodies to FVII | After 30 days |
| Number of Adverse Events | Until Day 5 |
| Number of Serious Adverse Events | Until Day 30 |
| Paris La Défense Cedex |
| 92932 |
| France |
| Novo Nordisk Investigational Site | Mainz | 55127 | Germany |
| Novo Nordisk Investigational Site | Vouliagment | 16671 | Greece |
| Novo Nordisk Investigational Site | Kowloon | Hong Kong |
| Novo Nordisk Investigational Site | Bangalore | 560001 | India |
| Novo Nordisk Investigational Site | Tehran | Iran |
| Novo Nordisk Investigational Site | Kfar Saba | 44425 | Israel |
| Novo Nordisk Investigational Site | Rome | 00144 | Italy |
| Novo Nordisk Investigational Site | Karachi | Pakistan |
| Novo Nordisk Investigational Site | Belgrade | 11070 | Serbia |
| Novo Nordisk Investigational Site | Bratislava | 811 05 | Slovakia |
| Novo Nordisk Investigational Site | Madrid | 28033 | Spain |
| Novo Nordisk Investigational Site | Bangkok | 10500 | Thailand |
| Novo Nordisk Investigational Site | Istanbul | 34335 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Caracas | Venezuela |
| Result |
| Mariani G, Dolce A, Napolitano M, Ingerslev J, Giansily-Blaizot M, Di Minno MD, Auerswald G, De Saez AR, Tagliaferri A, Batorova A; STER (Seven Treatment Evaluation Registry). Invasive procedures and minor surgery in factor VII deficiency. Haemophilia. 2012 May;18(3):e63-5. doi: 10.1111/j.1365-2516.2012.02751.x. Epub 2012 Feb 22. No abstract available. |