Emicizumab

Generic Name: Emicizumab

Brand Names: Hemlibra

Drug Type: Biotech

Chemical Formula: -

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 ...

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.
...

Associated Conditions: Bleeding caused by Hemophilia A

Associated Therapies: -

Clinical Trials

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

Phase 3

Active, not recruiting

Conditions: Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor
Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor
Hemophilia A

Interventions: Drug: Emicizumab

First Posted Date: 2019-11-12

Last Posted Date: 2024-12-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 73

Registration Number: NCT04158648

Locations: 🇳🇱
Amsterdam UMC Location AMC, Amsterdam, Netherlands
🇺🇸
Childrens Hospital LA, Los Angeles, California, United States
🇺🇸
Hemophilia of Georgia Center for Bleeding & Clotting Disorders, Atlanta, Georgia, United States

and more 20 locations

HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor

Phase 4

Terminated

Conditions: Haemophilic Pseudotumour

Interventions: Drug: Emicizumab

First Posted Date: 2019-04-19

Last Posted Date: 2024-04-11

Lead Sponsor: Indiana Hemophilia &Thrombosis Center, Inc.

Target Recruit Count: 1

Registration Number: NCT03921294

Locations: 🇺🇸
Indiana Hemophila @Thrombosis Center, Indianapolis, Indiana, United States

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Phase 1

Completed

Conditions: Hemophilia A
Healthy Volunteers

Interventions: Drug: Emicizumab

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

Phase 4

Terminated

Conditions: Hemophilia A

Interventions: Drug: Emicizumab

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

and more 5 locations

Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants

Phase 3

Active, not recruiting

Conditions: Hemophilia A

Interventions: Drug: Emicizumab

First Posted Date: 2017-10-20

Last Posted Date: 2024-06-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 85

Registration Number: NCT03315455

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing City, China
🇨🇳
Beijing Children's Hospital, Capital Medical University; rheumatism, Beijing City, China
🇨🇳
Ruijin Hospital Shanghai Jiaotong University School of Medicine; hemotology, Shanghai City, China

and more 10 locations

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Phase 3

Completed

Conditions: Hemophilia A

Interventions: Drug: Emicizumab

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

and more 69 locations

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A

Phase 3

Completed

Conditions: Hemophilia A

Interventions: Drug: Emicizumab

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

and more 14 locations

A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

Phase 3

Completed

Conditions: Hemophilia A

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

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

and more 36 locations

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

Phase 3

Completed

Conditions: Hemophilia A

Interventions: Drug: Emicizumab

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

and more 25 locations

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors

Phase 3

Completed

Conditions: Hemophilia A

Interventions: Drug: Emicizumab
Drug: rFVIIa
Drug: aPCC

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

and more 41 locations

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