Coagulation factor VIIa Recombinant Human
- Generic Name
- Coagulation factor VIIa Recombinant Human
- Brand Names
- Niastase RT, Novoseven, Sevenfact, NovoSeven
- Drug Type
- Biotech
- CAS Number
- 102786-61-8
- Unique Ingredient Identifier
- AC71R787OV
- Background
Recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues. Cloned and expressed in hamster kidney cells, the protein is catalytically active in a two-chain form.
- Indication
For treatment of hemorrhagic complications in hemophilia A and B.
- Associated Conditions
- Bleeding, Bleeding caused by Hemophilia A, Bleeding caused by Hemophilia B, Severe Bleeding
Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT®
- First Posted Date
- 2023-06-15
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Target Recruit Count
- 17
- Registration Number
- NCT05904210
- Locations
- 🇺🇸
Valley Children's Hospital, Madera, California, United States
🇺🇸Luskin Orthopaedic Institute for Children, Los Angeles, California, United States
🇺🇸Children's healthcare of Atlanta, Atlanta, Georgia, United States
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM
- First Posted Date
- 2023-01-25
- Last Posted Date
- 2024-09-27
- Lead Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Target Recruit Count
- 19
- Registration Number
- NCT05695391
- Locations
- 🇹🇷
Istanbul Üniversitesi Onkoloji Enstitusu, Fatih, Istanbul Province, Turkey
🇺🇸Orthopaedic Institute for Children - Orthopaedic Hemophilia Treatment Center, Los Angeles, California, United States
🇺🇸Children's Healthcare of Atlanta, Atlanta, Georgia, United States
NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL
- First Posted Date
- 2021-01-26
- Last Posted Date
- 2022-05-11
- Lead Sponsor
- Leiden University Medical Center
- Target Recruit Count
- 3322
- Registration Number
- NCT04723979
- Locations
- 🇳🇱
Leiden University Medical Center, Leiden, Netherlands
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
- First Posted Date
- 2020-09-24
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Emory University
- Target Recruit Count
- 5
- Registration Number
- NCT04563520
- Locations
- 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸Emory University Hospital, Atlanta, Georgia, United States
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
- Conditions
- Severe Postpartum Haemorrhage
- Interventions
- Other: Standard of care
- First Posted Date
- 2020-06-24
- Last Posted Date
- 2021-01-29
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 225
- Registration Number
- NCT04444856
- Locations
- 🇨🇭
Novo Nordisk Investigational Site, Bern, Switzerland
Injection of Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism(rPA)
- Conditions
- Acute Pulmonary Embolism
- Interventions
- First Posted Date
- 2019-10-01
- Last Posted Date
- 2019-10-11
- Lead Sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Target Recruit Count
- 174
- Registration Number
- NCT04110275
Recombinant Activated Factor VII in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia
- Conditions
- Massive Blood LossMassive Blood Transfusion; ThrombocytopeniaMassive Hemorrhage
- Interventions
- First Posted Date
- 2017-08-16
- Last Posted Date
- 2018-10-10
- Lead Sponsor
- Universiti Sains Malaysia
- Target Recruit Count
- 76
- Registration Number
- NCT03251547
- Locations
- 🇲🇾
Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
- Conditions
- Haemophilia B With InhibitorsCongenital Bleeding DisorderHaemophilia A With Inhibitors
- Interventions
- First Posted Date
- 2017-06-22
- Last Posted Date
- 2021-10-22
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 26
- Registration Number
- NCT03196284
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Sheffield, United Kingdom
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors
- First Posted Date
- 2015-12-04
- Last Posted Date
- 2021-06-24
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 113
- Registration Number
- NCT02622321
- Locations
- 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Boston Childrens Hospital, Boston, Massachusetts, United States
🇯🇵Hospital of the University of Occupational and Environmental Health,Japan, Kitakyushu-shi, Japan
Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors
- Conditions
- Hemophilia A With InhibitorsHemophilia B With Inhibitors
- Interventions
- First Posted Date
- 2015-06-29
- Last Posted Date
- 2019-08-28
- Lead Sponsor
- CSL Behring
- Target Recruit Count
- 25
- Registration Number
- NCT02484638
- Locations
- 🇬🇧
Site Reference # 8260008, London, United Kingdom
🇿🇦Site Reference # 7100001, Johannesburg, South Africa
🇮🇹Site Reference # 3800023, Milano, Italy
Drug Development Updates
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