重组人凝血因子Ⅶa(成都蓉生)(Recombinant human coagulation factor VIIa(Chengdu Rongsheng)) - 药物靶点：tissue factor_在研适应症：血友病_专利_临床

概要

基本信息

药物类型

重组凝血因子

别名-

靶点

tissue factor

作用机制

tissue factor抑制剂(组织因子抑制剂)

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

非在研适应症-

原研机构

成都蓉生药业有限责任公司

在研机构

成都蓉生药业有限责任公司

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

2

项与重组人凝血因子Ⅶa(成都蓉生) 相关的临床试验

CTR20231915 / Active, not recruiting临床3期

评价注射用重组人凝血因子Ⅶa对伴有凝血因子Ⅷ或Ⅸ抑制物的成人及青少年先天性血友病患者的有效性、安全性和药代动力学特征的单臂、开放、多中心临床试验

主要目的：评估注射用重组人凝血因子Ⅶa对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者按需治疗的有效性。次要目的：1）评估注射用重组人凝血因子Ⅶa 对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者按需治疗的安全性；2）评估注射用重组人凝血因子Ⅶa 对伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者的药代动力学特征。

开始日期2023-06-27

申办/合作机构

成都蓉生药业有限责任公司

CTR20211447 / Completed临床1期

评价注射用重组人凝血因子Ⅶa在伴有凝血因子Ⅷ或Ⅸ抑制物的血友病患者中单次给药后的安全性、耐受性和药代动力学特征的单臂、开放、剂量递增、多中心临床试验

主要目的：评估注射用重组人凝血因子Ⅶa在伴有凝血因子Ⅷ或Ⅸ抑制物的血友病（FⅧ活性水平≤1%或FⅨ活性水平≤2%）患者中单次给药后的安全性和耐受性。次要目的：评估注射用重组人凝血因子Ⅶa在伴有凝血因子Ⅷ或Ⅸ抑制物的血友病（FⅧ活性水平≤1%或FⅨ活性水平≤2%）患者中单次给药后的药代动力学特征。

开始日期2021-08-31

申办/合作机构

成都蓉生药业有限责任公司

100 项与重组人凝血因子Ⅶa(成都蓉生) 相关的临床结果

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100 项与重组人凝血因子Ⅶa(成都蓉生) 相关的转化医学

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100 项与重组人凝血因子Ⅶa(成都蓉生) 相关的专利（医药）

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67

项与重组人凝血因子Ⅶa(成都蓉生) 相关的文献（医药）

2024-03-01·BMJ Case Reports

Severe case of postpartum-acquired haemophilia A after laparoscopic cholecystectomy

Article

作者: Helmken, John Cord ; Camunas, Joseph A

Acquired factor VIII inhibitor, also known as acquired haemophilia A, has been associated with the postpartum state in young females. Treatment of acquired haemophilia A is focused on two goals: control of bleeding and eliminating the factor VIII inhibitor. Management requires successful intervention to accomplish both goals. Here, we describe the presentation and management of a case of acquired haemophilia A resulting in particularly severe and protracted intra-abdominal bleeding after routine laparoscopic cholecystectomy in a young and otherwise healthy female at 3 months postpartum. Due to diffuse intra-abdominal bleeding, she required return to the operating room on five occasions for intra-abdominal packing, reassessment of bleeding and ultimate fascial closure. Her abdomen was open for 5 days. She was treated with activated recombinant human factor VIIa to bypass inhibited factor VIII, and with immunosuppression using steroids, cyclophosphamide and anti-CD20 monoclonal antibody rituximab. She achieved remission after 6 weeks of treatment.

2023-10-01·Polski Merkuriusz Lekarski

COMPARING THE EFFECTIVENESS OF CONCENTRATE OF ALL PROTHROMBIN COMPLEX FACTORS WITH RECOMBINANT HUMAN COAGULATION FACTOR VIIa IN THE TREATMENT OF BLEEDING AFTER CARDIAC SURGERY

Article

作者: Zagórski, Maciej ; Sejboth, Justyna

Aim: The authors evaluated the effectiveness of treatment with recombinant human coagulation factor VIIa and concentrate of all prothrombin complex factors in patients with massive postoperative bleeding that could not be controlled with traditional therapy. Materials and Methods: In the period from 2020 to 2021, recombinant human coagulation factor VIIa was administered to 18 patients after cardiac surgery (group I), while the concentrate of all prothrombin complex factors was administered to 16 patients postoperatively (group II). During this period, 647 patients were operated on. The patients had normal coagulation screening tests (APTT, INR, TT, fibrinogen level, and PLT level) before surgery. Mean blood loss before and after administration of eptacog alfa and the total prothrombin complex concentrate was assessed. The mean dose of eptacog alfa was 30.95 mcg/kg b.w., and the total prothrombin complex factor concentrate dose was 14.17 mcg/kg b.w. After transfusion with red blood cell concentrate, fresh frozen plasma, and platelet concentrate, in the absence of improvement in the dynamics of postoperative drainage, it was decided to include recombinant human coagulation factor VIIa or a concentrate of all prothrombin complex factors in the treatment. Results: After administration of recombinant human coagulation factor VIIa at a dose of 30.95 mcg/kg b.w., bleeding stopped in 12 patients, but the remaining 6 patients required reoperation due to persistently high drainage. The decision to perform a rethoracotomy was made by a team of cardiothoracic surgeons and anesthesiologists, taking into account the dynamics of drainage (bleeding) and the hemodynamic stability of the patient. After the administration of concentrate of all prothrombin complex factors at a dose of 14.17 U/kg b.w., bleeding stopped in 12 patients. Four patients required reoperation due to persistent bleeding. Conclusions: Treatment with recombinant human coagulation factor VIIa and concentrate of all prothrombin complex factors is effective and safe for cardiac surgery patients.

2023-05-01·Journal of Veterinary Emergency and Critical Care

Use of recombinant human factor VIIa in 2 patients with postoperative noncompressible, abdominal hemorrhage

作者: Walton, Rebecca ; Zorn, Chelsea M. ; Blong, April E.

AbstractObjectiveTo describe the clinical presentation, clinical course, and successful management of noncompressible, abdominal hemorrhage with recombinant human factor VIIa (rFVIIa) in 2 postoperative patients.Case SummaryA 14‐year‐old neutered female Border Terrier and a 9‐year‐old neutered male domestic shorthair were treated with rFVIIa to treat noncompressible abdominal hemorrhage in the postoperative period. The dog presented for a septic abdomen following endoscopic intestinal biopsies 10 days prior and was found to have a jejunal perforation along with a fractured liver lobe and hepatic lymphoma at the time of exploratory laparotomy. The cat presented for a spontaneous hemoabdomen associated with hepatic amyloidosis. Clinically significant hemorrhage occurred in the perioperative and postoperative period and both patients received massive transfusions and antifibrinolytic therapy. Despite these interventions, the patients continued to have ongoing abdominal hemorrhage and surgical attempts at hemostasis were not attempted due to the friable nature of the liver at the time of surgery. Both patients received rFVIIa intravenously every 3 hours at a dose between 70 and 90 μg/kg as indicated by the clinical picture, which subsequently decreased transfusion requirements.New or Unique Information ProvidedThis case report describes the use of rFVIIa in a cat and a dog with severe, noncompressible abdominal hemorrhage in combination with standard hemostatic interventions.

100 项与重组人凝血因子Ⅶa(成都蓉生) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
血友病	临床3期	中国	成都蓉生药业有限责任公司	2023-06-27

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| J Cardiothorac Vasc Anesth	N/A	-	-	Recombinant Human Factor VIIa	蓋構觸網積壓鑰夢願齋(淵製齋鬱醖願齋築壓鹹): HR = 2.168, P-Value = 0.057	-	2020-11-01
				Recombinant Human Factor VIIa