Factor IX complex(Grifols)(Factor IX complex(Grifols)) - 药物靶点：F10 x factor IX x factor VII x thrombin_在研适应症：血友病B_专利_临床

概要

基本信息

药物类型

非重组凝血因子

别名

Alphanine、Alphanine Hp、Alphanine Sd

+ [4]

靶点

F10 x factor IX x factor VII x thrombin

作用机制

F10调节剂(凝血因子X调节剂)、factor IX调节剂(凝血因子IX调节剂)、factor VII调节剂(凝血因子VII调节剂)

+ [1]

治疗领域

遗传病与畸形血液及淋巴系统疾病其他疾病

在研适应症

血友病B

非在研适应症-

原研机构

Grifols Biologicals, Inc.

在研机构

Grifols Biologicals, Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (1981-07-20),

血友病B

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 207242

关联

2

项与 Factor IX complex(Grifols) 相关的临床试验

NCT01656330 / Completed临床1期

Randomized, Parallel-Group, Open-Label Study to Assess the Effects of 3-Factor and 4-Factor Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban

The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.

开始日期2012-07-01

申办/合作机构

Janssen Research & Development LLC

[+1]

EUCTR2008-002037-67-BG / Not yet recruitingN/A

EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B)

开始日期2008-08-15

申办/合作机构

Grifols Biologicals, Inc.

100 项与 Factor IX complex(Grifols) 相关的临床结果

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100 项与 Factor IX complex(Grifols) 相关的转化医学

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100 项与 Factor IX complex(Grifols) 相关的专利（医药）

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30

项与 Factor IX complex(Grifols) 相关的文献（医药）

2019-09-02·International Journal of Neuroscience4区 · 医学

Bilateral subthalmic nucleus deep brain stimulation with microelectrode recordings in the setting of mild inherited hemophilia B: a case report

4区 · 医学

Article

作者: Nazzaro, Jules M. ; Yacoub, Abdulraheem ; Mohyuddin, Ghulam Rehman

Hemophilia B is an X linked recessive deficiency of factor IX that presents with a range of clinical severity that co-relates with factor levels. Although guidelines exist to guide perioperative hemostasis in such patients, there is scarce data on elective high-risk neurosurgeries, resulting in a reluctance to offer these patients elective neurosurgeries. These patients thus rarely if ever undergo such procedures. We report a unique case of undiagnosed mild hemophilia B in a gentleman that was found incidentally at age 64 during pre-operative workup. This gentleman had intractable Parkinson's disease for which subthalmic deep brain stimulation was indicated. He was found to have a prolonged APTT on initial lab testing. After subsequent workup, and having excluded the presence of inhibitors, he was diagnosed with Hemophilia B. With the use of Factor IX concentrates (AlphaNine®) and close clinical, laboratory, and radiological monitoring a plan was made for this patient to undergo this procedure. Our patient successfully underwent subthalmic deep brain stimulation with microelectrode recordings and intraoperative test stimulation in a two-step procedure, followed by single channel implantable neurostimulator and extension wire implantations 2 weeks later. The successful peri-operative course of this patient using this novel approach is described, and the need for future data in this regard is emphasized.

2019-05-01·Vox Sanguinis

Three‐factor prothrombin complex concentrates for refractory bleeding after cardiovascular surgery within an algorithmic approach to haemostasis

Article

作者: Ghadimi, Kamrouz ; Ortel, Thomas L. ; Hashmi, Nazish K. ; Raiff, Robert D. ; Barac, Yaron D. ; Srinivasan, Amudan J. ; Levy, Jerrold H. ; Li, Yi‐Ju ; Root, Adam G. ; Gaca, Jeffrey G. ; Welsby, Ian J.

Background/ObjectivesProthrombin complex concentrates (PCC) are increasingly administered off‐label in the United States to treat bleeding in cardiovascular surgical patients and carry the potential risk for acquired thromboembolic side‐effects after surgery. Therefore, we hypothesized that the use of low‐dose 3‐factor (3F) PCC (20‐30 IU/kg), as part of a transfusion algorithm, reduces bleeding without increasing postoperative thrombotic/thromboembolic complications.Materials/MethodsAfter IRB approval, we retrospectively analysed 114 consecutive, complex cardiovascular surgical patients (age > 18 years), between February 2014 and June 2015, that received low‐dose 3F‐PCC (Profilnine®), of which seven patients met established exclusion criteria. PCC was dosed according to an institutional perioperative algorithm. Allogeneic transfusions were recorded before and after PCC administration (n = 107). The incidence of postoperative thromboembolic events was determined within 30 days of surgery, and Factor II levels were measured in a subset of patients (n = 20) as a quality control measure to avoid excessive PCC dosing.ResultsTotal allogeneic blood product transfusion reached a mean of 12·4 ± 9·9 units before PCC and 5·0 ± 6·3 units after PCC administration (P < 0·001). The mean PCC dose was 15·8 ± 7·1 IU/kg. Four patients (3·8%) each experienced an ischaemic stroke on postoperative day 1, 2, 4 and 27. Seven patients (6·5%) had acquired venous thromboembolic disease within 10 days of surgery. Median factor II level after transfusion algorithm adherence and PCC administration was 87%.Conclusions3F‐PCC use for refractory bleeding after cardiovascular surgery resulted in reduced transfusion of allogeneic blood and blood products. Adherence to this algorithmic approach was associated with an acceptable incidence of postoperative thrombotic/thromboembolic complications.

2016-07-01·Journal of Thrombosis and Thrombolysis4区 · 医学

Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates

4区 · 医学

Article

作者: Coons, James C ; Saul, Melissa ; Smith, Roy E ; Hedges, Ashley

Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb <7 g/L (n = 13), the median time to Hgb >7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma.

100 项与 Factor IX complex(Grifols) 相关的药物交易

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