An observational study in Congenital Bleeding Disorder and Congenital FVII Deficiency, sponsored by Novo Nordisk A/S. Completed at 16 sites in 16 countries. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Novo Nordisk A/S · Observational
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 163 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Drug: activated recombinant human factor VII · Drug: Fresh frozen plasma (Source unspecified) · Drug: Plasma-derived FVII (LFB) · Drug: Prothrombin Complex conc. (PCC) · Drug: Plasma-derived FVII conc. (pdFVII Baxter) · Drug: Plasma-derived FVII conc. (pdFVII PFL)
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
Treatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable
Time frame: 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
Time frame: Evaluated after 30 days
Treatment of bleeding episodes at clinic/hospital: Time to achieve arrest of bleeding
Time frame: Time to achieve arrest of bleeding
Treatment of bleeding episodes at clinic/hospital: Number of re-bleeding episodes
Time frame: 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
Time frame: Evaluated at 6 hours
Treatment of bleeding episodes at home: Time to achieve arrest of bleeding
Time frame: 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
Time frame: After surgery
Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective
Time frame: Evaluated after 30 days
Estimated blood loss volume
Time frame: During surgery/delivery
Number of red blood cell units administered
Time frame: During surgery
Number of days spent in hospital
Time frame: Until last data collection (20 Jan 2012)
Number of re-bleeding episodes (associated with the surgery)
Time frame: Within 5 days after surgery
Prophylactic treatment efficacy evaluation: excellent, excellent, partially effective, or effective
Time frame: 30 days after first prophylaxis dose
Number of bleeding episodes during prophylaxis per year
Time frame: Up to one year
Number of intensive care unit (ICU) and/or the number of ward days
Time frame: After first haemostatic product administration until day 30
Mortality
Time frame: 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)
Time frame: Prior to dosing
Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)
Time frame: After 15 minutes
Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)
Time frame: After 30 days
Presence of and/or de novo appearance of inhibiting antibodies to FVII
Time frame: Prior to dosing
Presence of and/or de novo appearance of inhibiting antibodies to FVII
Time frame: After 30 days
Number of Adverse Events
Time frame: Until Day 5
Number of Serious Adverse Events
Time frame: Until Day 30
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S