Delving into the Latest Updates on Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

Target

tissue factor

Mechanism

tissue factor inhibitors(Tissue factor inhibitors)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia AHemophilia BPostoperative Hemorrhage+ [1]

Inactive Indication

Neuropathy, Distal Hereditary Motor, Type VIIA

Originator Organization

Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

Active Organization

Nanjing Shunxin Pharmaceutical Co., Ltd.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Primary objective: To evaluate the efficacy and safety of recombinant human coagulation factor VIIa for injection in patients with congenital hemophilia A or B. Secondary objective: To evaluate the activity recovery rate of recombinant human coagulation factor VIIa for injection after repeated administration and to observe whether it is time-dependent.

Start Date27 Apr 2022

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

CTR20202311 / CompletedPhase 1

注射用重组人凝血因子VIIa在伴有抑制物血友病患者中的药代及药效学（PK/PD）试验

[Translation] Pharmacokinetic and pharmacodynamic (PK/PD) study of recombinant human coagulation factor VIIa for injection in hemophilia patients with inhibitors

评价注射用重组人凝血因子VIIa 在伴有抑制物血友病患者中的PK/PD 特征。

[Translation]

To evaluate the PK/PD characteristics of recombinant human coagulation factor VIIa for injection in hemophilia patients with inhibitors.

Start Date15 Dec 2020

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

NCT04768699 / Unknown statusPhase 1

A Dose-ascending Study to Evaluate the Pharmacokinetics and Pharmacodynamics (PK/PD) of Recombinant Human Coagulation Factor VIIa for Injection in Patients With Hemophilia.

Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.

Start Date01 Dec 2020

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.)

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100 Translational Medicine associated with Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.)

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100 Patents (Medical) associated with Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.)

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2

Literatures (Medical) associated with Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.)

Hematology Reports

Acquired hemophilia A developing cerebral infarction 36 days after the frequent administration of bypass hemostatic agents

Article

Author: Mori, Akio ; Saito, Makoto ; Morioka, Masanobu ; Kanaya, Minoru ; Izumiyama, Koh ; Senjo, Hajime ; Ieko, Masahiro ; Tanaka, Masanori

A 74-years-old male who was a smoker and received treatment for hypertension, dyslipidemia, peripheral arterial disease and idiopathic interstitial pneumonia complained of subcutaneous hemorrhage of the right lower thigh. Marked anemia (hemoglobin 5.5 g/dL) and prolonged activated partial thromboplastin time (≥130 seconds) were noted. The factor VIII activity level was reduced to 1.2 %, and the factor VIII inhibitor titer was 285.3 BU/mL, a diagnosis of acquired hemophilia A (AHA) was made. Then, hematomas of 5 intra-muscles were recurred. Hemostasis became difficult despite frequent and high-dose administration of recombinant human coagulation factor VIIa (total: 18 days, 305 mg). Hemostasis was achieved by switching to activated prothrombin complex concentrate (for 3 days, 18,000 units), however, cerebral infarction occurred after 36 days. After the frequent administration of bypass hemostatic agents on elderly AHA patients with several risk factors for ischemic stroke, the risk of subsequent thrombotic events may persist for 1 month.

Hepato-gastroenterology

Splenic embolization in a Jehovah's Witness: role of recombinant human factor VIIa.

Article

Author: Bejna, Judy ; Van Thiel, David H ; George, Magdalene ; Anantharaju, Abhinandana ; Mindikoglu, Ayse L ; Leone, Nancy

A case of a 50-year-old Jehovah's Witness with cryptogenic cirrhosis, severe portal hypertension and a coagulopathy, who underwent splenic embolization to improve the platelet count after receiving recombinant human Factor VIIa, is reported. Following the infusion of recombinant human Factor VIIa, the coagulopathy was rapidly corrected and it became possible to safely embolize her spleen. The changes in prothrombin time, international normalized ratio and activated partial thromboplastin time as well as thrombomodulin, tissue factor and plasminogen activator inhibitor after the infusion are presented. As a result of the splenic embolization, her platelet count normalized and she has been listed for liver transplantation.

100 Deals associated with Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	NDA/BLA	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	14 Dec 2023
Hemophilia B	NDA/BLA	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	14 Dec 2023
Postoperative Hemorrhage	NDA/BLA	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	14 Dec 2023
Hemophilia	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	27 Apr 2022
Neuropathy, Distal Hereditary Motor, Type VIIA	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	15 Dec 2020