Nonacog beta pegol
- Generic Name
- Nonacog beta pegol
- Brand Names
- Refixia
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1175512-71-6
- Unique Ingredient Identifier
- 27Y83O992Q
- Background
Nonacog beta pegol is a recombinant coagulation factor IX derivative. It is produced without animal-derived materials and with an attached 40kDa polyethylene glycol (PEG) molecule for peptide activation by a site-directed glycoPEGylation. Once activated, the activation molecule with PEG is cleaved to leave the activated factor IX (Factor IXa). Nonacog beta pegol was developed by Novo Nordisk and received its first global approval by the FDA on May 31, 2017, followed by the European Commission approval on June 2, 2017. Nonacog beta pegol was approved by Health Canada on November 29, 2017.
- Indication
Nonacog beta pegol is indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for control and prevention of bleeding episodes as well as control and prevention of bleeding in the perioperative setting. It is also used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
- Associated Conditions
- Bleeding caused by Hemophilia B
- Associated Therapies
- Perioperative management therapy
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
- First Posted Date
- 2022-05-09
- Last Posted Date
- 2024-07-15
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 30
- Registration Number
- NCT05365217
- Locations
- 🇨🇳
The Affiliated hospital of Guizhou Medical University-Hemato, Guiyang, Guizhou, China
🇨🇳Beijing Children's Hospital，Capital Medical University, Beijing, Beijing, China
🇨🇳Fujian Medical University Union Hospital-Hematology, Fuzhou, Fujian, China
A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
- Conditions
- Interventions
- First Posted Date
- 2018-11-19
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 60
- Registration Number
- NCT03745924
- Locations
- 🇩🇪
Vivantes Klinikum am Friedrichshain - Innere Medizin - Angiologie und Hämostaseologie, Berlin, Germany
🇩🇪Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie, Bonn, Germany
🇦🇹AKH - Klin. Abt. f. Haematologie u. Haemostaseologie, Wien, Austria
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
- Conditions
- Interventions
- First Posted Date
- 2018-10-01
- Last Posted Date
- 2024-02-02
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 10
- Registration Number
- NCT03690336
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Sheffield, United Kingdom
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
- Conditions
- Interventions
- First Posted Date
- 2014-05-19
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 54
- Registration Number
- NCT02141074
- Locations
- 🇺🇸
Univ of Utah Primary Children's Hospital, Salt Lake City, Utah, United States
🇦🇹Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie, Graz, Austria
🇬🇧Birmingham Children's Hospital, Birmingham, United Kingdom
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
- Conditions
- Interventions
- First Posted Date
- 2011-11-08
- Last Posted Date
- 2024-04-02
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 25
- Registration Number
- NCT01467427
- Locations
- 🇺🇸
Maimonides Medical Center, Brooklyn, New York, United States
🇺🇸Mount Sinai Medical Center, New York, New York, United States
🇺🇸University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
- Conditions
- Interventions
- First Posted Date
- 2011-07-18
- Last Posted Date
- 2018-05-09
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 71
- Registration Number
- NCT01395810
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Oxford, United Kingdom
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
- Conditions
- Interventions
- First Posted Date
- 2011-07-01
- Last Posted Date
- 2017-08-23
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 13
- Registration Number
- NCT01386528
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Oxford, United Kingdom
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
- Conditions
- Interventions
- First Posted Date
- 2011-04-11
- Last Posted Date
- 2017-07-28
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 74
- Registration Number
- NCT01333111
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Oxford, United Kingdom
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
- Conditions
- Interventions
- First Posted Date
- 2009-08-11
- Last Posted Date
- 2017-01-20
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 18
- Registration Number
- NCT00956345
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Oxford, United Kingdom
Drug Development Updates
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