Entering new areas in known fields: recombinant fusion protein linking recombinant factor VIIa with recombinant albumin (rVIIa-FP) – advancing the journey

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Pharmacological characteristics of a novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)

BACKGROUND Recombinant factor VIIa (rFVIIa) is approved for use in controlling bleeding episodes in people with hemophilia who have developed inhibitors to replacement therapy. Due to its short half-life (t½), frequent injections are required, limiting its use as a prophylactic treatment. A novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) has been develo...

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Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children

A global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1-11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any b...

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The Use of Recombinant Factor VIIa*

As described in detail in other chapters of this volume, conditions with excessive bleeding, as are seen with uterine rupture, placenta accreta, abruption and uterine atony, often require intensive resuscitation with blood components and coagulation factors. In such circumstances, blood transfusion may be life-saving, but on occasion involves exposing the patient to additional risks. Over the y...

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Use of Recombinant factor VIIa in Obstetrics

6 The objective of this review article was to evaluate the current literature on the increasing off-label use of rFVIIa in the management of critical obstetric hemorrhage. Given the lack of high-level evidence, there is a need to review the clinical indications, observed response and adverse events. This review is designed to aid practitioners in deciding when and how to administer rFVIIa; It m...

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EVIDENCE DEFINITIONS • Class I: Prospective randomized controlled trial. • Class II: Prospective clinical study or retrospective analysis of reliable data. Includes observational, cohort, prevalence, or case control studies. • Class III: Retrospective study. Includes database or registry reviews, large series of case reports, expert opinion. • Technology assessment: A technology study which doe...

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ژورنال

عنوان ژورنال: Thrombosis Research

سال: 2016

ISSN: 0049-3848

DOI: 10.1016/s0049-3848(16)30416-9