Emicizumab
- Generic Name
- Emicizumab
- Brand Names
- Hemlibra
- Drug Type
- Biotech
- CAS Number
- 1610943-06-0
- Unique Ingredient Identifier
- 7NL2E3F6K3
- Background
Emicizumab is a humanized recombinant monoclonal antibody that mimics the function of the coagulation Factor VIII and it has the capacity to bind simultaneously to activated Factor IX and Factor X. The ability of Emicizumab to bind to all these three different factors allows it to overcome immunogenicity and unstable hemostatic efficacy produced by previous Factor VII agents. Emicizumab was originated as an improved form of hBS23 and it was approved on November 16, 2017. It was created by Chugai Pharmaceuticals Co. Ltd. and co-developed with Roche and Genentech.
- Indication
The main function of Emicizumab is the prevention of bleeding episodes. Thus, Emicizumab is approved for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes of adult and pediatric patients with hemophilia A with or without Factor VIII inhibitors.
Hemophilia A is a deficiency of coagulation Factor VIII which causes a serious bleeding disorder. The standard treatment is done with the administration of recombinant or serum-deriver Factor VIII which induces the formation of anti-factor VIII alloantibodies (Factor VIII inhibitors) and renders the standard treatment ineffective.
- Associated Conditions
- Bleeding caused by Hemophilia A
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
- First Posted Date
- 2017-12-21
- Last Posted Date
- 2019-09-30
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 16
- Registration Number
- NCT03380780
- Locations
- 🇨🇳
Peking University Third Hospital, Beijing, China
Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
- First Posted Date
- 2017-12-04
- Last Posted Date
- 2021-03-01
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 14
- Registration Number
- NCT03361137
- Locations
- 🇺🇸
Childrens Hospital of LA, Los Angeles, California, United States
🇺🇸Indiana Hemophilia & Thrombosis center, Indianapolis, Indiana, United States
🇺🇸Newark Beth Israel Medical Center, Newark, New Jersey, United States
Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants
- First Posted Date
- 2017-10-20
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 85
- Registration Number
- NCT03315455
- Locations
- 🇨🇳
Beijing Children's Hospital, Capital Medical University, Beijing City, China
🇨🇳Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai City, China
🇭🇰Queen Mary Hospital, Hong kong, Hong Kong
A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
- First Posted Date
- 2017-06-19
- Last Posted Date
- 2021-06-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 195
- Registration Number
- NCT03191799
- Locations
- 🇨🇦
Kaye Edmonton Clinic, Edmonton, Alberta, Canada
🇩🇪Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin, Bonn, Germany
🇩🇪Vivantes Klinikum im Friedrichshain - Landsberger Allee, Angiologie und Hämostaseologie, Berlin, Germany
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A
- First Posted Date
- 2017-01-13
- Last Posted Date
- 2023-01-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 48
- Registration Number
- NCT03020160
- Locations
- 🇦🇺
Royal Brisbane Hospital; Clinical Haematology, Brisbane, Queensland, Australia
🇯🇵National Center for Child Health and Development, Tokyo, Japan
🇺🇸University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors
- First Posted Date
- 2016-07-28
- Last Posted Date
- 2022-11-16
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 152
- Registration Number
- NCT02847637
- Locations
- 🇮🇹
AOU Careggi; SOD Malattie Emorragiche, Firenze, Toscana, Italy
🇺🇸University of Florida, Gainesville, Florida, United States
🇩🇪Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin, Bonn, Germany
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
- First Posted Date
- 2016-06-10
- Last Posted Date
- 2021-06-02
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 88
- Registration Number
- NCT02795767
- Locations
- 🇺🇸
Rush Medical Center, Chicago, Illinois, United States
🇺🇸Children's Hospital of Michigan; Pediatrics, Detroit, Michigan, United States
🇺🇸North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation, New Hyde Park, New York, United States
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
Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform
- Conditions
- Severe Hemophilia A
- Interventions
- First Posted Date
- 2014-07-21
- Last Posted Date
- 2019-08-20
- Lead Sponsor
- Margaret Ragni
- Registration Number
- NCT02196207
- Locations
- 🇺🇸
Hemophilia Center of Western Pennsylvania, Pittsburgh, Pennsylvania, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.