NEWS HIGHLIGHTS
Published Studies Related to Novoseven (Coagulation Factor Viia)
Xa inhibition and coagulation activity--the influence of prolonged dalteparin treatment and gender in patients with acute coronary syndrome and healthy individuals. [2008.03]
BACKGROUND: We evaluated coagulation activity in relation to gender in patients with acute coronary syndromes and in healthy individuals of similar age, and related coagulation activity to levels of Xa inhibition during dalteparin treatment... CONCLUSIONS: Despite weight-adjusted dosing, female patients reached higher anti-Xa levels, suggesting increased sensitivity to dalteparin treatment. Healthy women and female patients also had higher coagulation activity, which might increase the risk of thrombus formation. The large proportion of patients with subtherapeutic anti-Xa during prolonged dalteparin treatment may reflect poor compliance and could thus contribute to the gradual loss of clinical efficacy.
Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. [2005.05]
BACKGROUND: Activated recombinant coagulation factor VII (rFVIIa) effectively prevents and controls bleeding in patients with coagulopathy. Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery. We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum, who were expected to have a large volume of blood loss... CONCLUSIONS: In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture, the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss.
Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. [2005.02]
BACKGROUND: Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy... CONCLUSIONS: Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered. No safety issues were identified.
Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. [2004.07]
To establish the pharmacokinetic profile of activated recombinant coagulation factor VII (rFVIIa; NovoSeven in children with haemophilia A, and to compare it with the pharmacokinetic profile in adults with haemophilia A. Twelve children (2-12 years) received one single dose of rFVIIa 90 and 180 micrograms kg(-1) in randomized order separated by a washout period of 48 h to 1 month...
Effect of individual dietary fatty acids on postprandial activation of blood coagulation factor VII and fibrinolysis in healthy young men. [2003.05]
BACKGROUND: Hypertriglyceridemia may represent a procoagulant state involving disturbances to the hemostatic system. Plasminogen activator inhibitor type 1 (PAI-1) is increased in the presence of hypertriglyceridemia. Free fatty acids (FFAs) in plasma may promote factor VII (FVII) activation. OBJECTIVE: We tested the hypothesis that FVII activation would be less after consumption of saturated fatty acids than after other fatty acids... CONCLUSION: Our results indicate a lesser increase in FVIIa after the consumption of saturated fats, especially the S fat, than after unsaturated test fats.
Clinical Trials Related to Novoseven (Coagulation Factor Viia)
Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation [Completed]
The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on
restoring coagulation activation between patients with hemophilia A and antibodies to factor
VIII and normal subjects (controls) by use of an in vivo method.
The FEIBA NovoSeven Comparative Study [Completed]
FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate
and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the
treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study
is designed as a clinical equivalency trial.
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia [Completed]
This trial is conducted in Africa, Asia, Europe, South America, and the United States of
America (USA).
The purpose of this study is to evaluate the effectiveness of secondary prophylactic
treatment with NovoSeven® in haemophilia A and B patients with inhibitors.
Trial of NovoSeven® in Hemophilia - Joint Bleeds [Completed]
This trial is conducted in the United States of America (USA).
This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in
hemophilia patients with inhibitors being treated for joint bleeds.
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors [Recruiting]
This study is conducted in Europe. The primary objective of this registry is to observe the
use of single dose and multi-dose use of NovoSeven® and to compare short-term outcomes,
including effectiveness, safety, quality of life and treatment satisfaction with the
approved treatments.
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