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

Clinical Trials

Low Dose Emicizumab vs Low Dose Factor VIII in Prophylaxis in Hemophilia A Patients

Phase 2

Not yet recruiting

Conditions: Hemophilia A

Interventions: Drug: Emicizumab Injection
Drug: Factor VIII (FVIII)

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-22

Lead Sponsor: Dhaka Medical College

Target Recruit Count: 20

Registration Number: NCT06938659

Locations: 🇧🇩
Dhaka Medical College Hospital, Dhaka, Bangladesh

Health-Related Quality of Life Outcomes and Bleeding Rates Among Patients With Severe Hemophilia A on Emicizumab

Not yet recruiting

Conditions: Hemophilia A

First Posted Date: 2023-10-27

Last Posted Date: 2023-10-30

Lead Sponsor: Newark Beth Israel Medical Center

Target Recruit Count: 50

Registration Number: NCT06104826

Locations: 🇺🇸
Newark Beth Israel Medical Center, Newark, New Jersey, United States

Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A

Phase 1

Recruiting

Conditions: Concomitant VWD and Hemophilia
Von Willebrand Disease, Type 3

Interventions: Drug: Emicizumab

First Posted Date: 2022-08-15

Last Posted Date: 2023-03-01

Lead Sponsor: Bleeding and Clotting Disorders Institute Peoria, Illinois

Target Recruit Count: 40

Registration Number: NCT05500807

Locations: 🇺🇸
Bleeding and Clotting Disorders Institute, Peoria, Illinois, United States

Emicizumab in Patients With Acquired Hemophilia A

Phase 2

Recruiting

Conditions: Acquired Hemophilia A

Interventions: Drug: emicizumab

First Posted Date: 2022-04-25

Last Posted Date: 2025-01-28

Lead Sponsor: University of Washington

Target Recruit Count: 51

Registration Number: NCT05345197

Locations: 🇺🇸
Hemophilia Center of Western Pennsylvania, Pittsburgh, Pennsylvania, United States
🇺🇸
UVA Comprehensive Cancer Center, Charlottesville, Virginia, United States
🇺🇸
UCSD Hemophilia and Thrombosis Treatment Center, San Diego, California, United States

and more 13 locations

Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast

Not Applicable

Completed

Conditions: Hemophilia A

Interventions: Drug: Prophylaxis with Emicizumab

First Posted Date: 2022-03-15

Last Posted Date: 2022-10-26

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 33

Registration Number: NCT05279924

Locations: 🇨🇮
CHU de Yopougon, Abidjan, Côte D'Ivoire

Real World Use of Emicizumab in Infants and Children Ages 0-3 Years With Hemophilia A

Recruiting

Conditions: Hemophilia A

First Posted Date: 2022-02-21

Last Posted Date: 2025-02-03

Lead Sponsor: Montefiore Medical Center

Target Recruit Count: 50

Registration Number: NCT05248594

Locations: 🇺🇸
Connecticut Children's Hemophilia Treatment Center - Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸
Yale Hemophilia Treatment Center, New Haven, Connecticut, United States
🇺🇸
Dartmouth Hitchcock Hemophilia Center - Mary Hitchcock Memorial Hospital, Lebanon, New Hampshire, United States

and more 7 locations

A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

Phase 4

Active, not recruiting

Conditions: Severe Hemophilia A
Moderate Hemophilia A

Interventions: Drug: Emicizumab

First Posted Date: 2022-01-06

Last Posted Date: 2025-05-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 136

Registration Number: NCT05181618

Locations: 🇮🇹
Policlinico Univ. A. Gemelli, Roma, Lazio, Italy
🇮🇹
AOU Careggi, Firenze, Toscana, Italy
🇪🇸
Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruna, Spain

and more 24 locations

Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis

Recruiting

Conditions: Hemophilia A

Interventions: Drug: FVIII
Drug: Emicizumab

First Posted Date: 2021-08-26

Last Posted Date: 2025-05-06

Lead Sponsor: Wayne State University

Target Recruit Count: 120

Registration Number: NCT05022459

Locations: 🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States

and more 4 locations