Fibrinogen Concentrate(CSL Behring)(Fibrinogen Concentrate(CSL Behring)) - 药物靶点：GP IIb/IIIa_专利_临床

概要

基本信息

药物类型

重组凝血因子

别名

CSL511 Fibrinogen concentrate、CSL-511

靶点

GP IIb/IIIa

作用方式

调节剂

作用机制

GP IIb/IIIa modulators(糖蛋白 IIb/IIIa调节剂)

治疗领域-

在研适应症-

非在研适应症-

原研机构

CSL Behring LLC

在研机构

CSL Behring LLC

非在研机构-

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

2

项与 Fibrinogen Concentrate(CSL Behring) 相关的临床试验

NCT06617897

/ Recruiting临床3期

A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.

开始日期2024-10-01

申办/合作机构

CSL Behring LLC

NCT01475669

/ Completed临床3期

REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery

The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine.
The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.

开始日期2012-01-01

申办/合作机构

CSL Behring LLC

100 项与 Fibrinogen Concentrate(CSL Behring) 相关的临床结果

登录后查看更多信息

100 项与 Fibrinogen Concentrate(CSL Behring) 相关的转化医学

登录后查看更多信息

100 项与 Fibrinogen Concentrate(CSL Behring) 相关的专利（医药）

登录后查看更多信息

2

项与 Fibrinogen Concentrate(CSL Behring) 相关的文献（医药）

2017-08-01·The Lancet. Haematology1区 · 医学