MedPath

Crovalimab

Generic Name
Crovalimab
Brand Names
-
Drug Type
Biotech
Chemical Formula
-
CAS Number
1917321-26-6
Unique Ingredient Identifier
H9KH1GP3UU
Background

Crovalimab is under investigation in clinical trial NCT03157635 (Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria).

Indication

用于未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症(属罕见病)成人和青少年(≥12岁)患者。

Associated Conditions
-
Associated Therapies
-

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)

Phase 3
Withdrawn
Conditions
Guillain-Barré Syndrome
Interventions
Drug: Placebo
Drug: Crovalimab
Drug: Intravenous immunoglobulin therapy
First Posted Date
2022-08-10
Last Posted Date
2022-12-15
Lead Sponsor
Hoffmann-La Roche
Registration Number
NCT05494619

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

Phase 2
Active, not recruiting
Conditions
Sickle Cell Disease
Interventions
Drug: Crovalimab
Drug: Placebo
First Posted Date
2021-10-13
Last Posted Date
2024-12-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
90
Registration Number
NCT05075824
Locations
🇺🇸

Children's Hospital of Michigan, Detroit, Michigan, United States

🇺🇸

East Carolina University, Greenville, North Carolina, United States

🇫🇷

CHU Henri Mondor, Créteil, France

and more 27 locations

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3
Recruiting
Conditions
Atypical Hemolytic Uremic Syndrome
Interventions
First Posted Date
2021-07-12
Last Posted Date
2025-01-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
45
Registration Number
NCT04958265
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center; Investigational Drug Services, Cincinnati, Ohio, United States

🇮🇳

All India Institute Of Medical Sciences (AIIMS), New Delhi, Delhi, India

🇺🇸

UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr, San Antonio, Texas, United States

and more 46 locations

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

Phase 1
Recruiting
Conditions
Sickle Cell Disease
Interventions
Drug: Placebo
Drug: Crovalimab
First Posted Date
2021-06-03
Last Posted Date
2024-12-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
30
Registration Number
NCT04912869
Locations
🇺🇸

Children'S Healthcare of Atlanta, Atlanta, Georgia, United States

🇺🇸

Children's Hospital of Michigan; Pediatrics, Detroit, Michigan, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 20 locations

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3
Recruiting
Conditions
Atypical Hemolytic Uremic Syndrome
Interventions
First Posted Date
2021-04-27
Last Posted Date
2025-01-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
80
Registration Number
NCT04861259
Locations
🇧🇪

UZ Leuven Gasthuisberg, Leuven, Belgium

🇧🇷

UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil

🇧🇷

Hospital das Clinicas - FMUSP, Sao Paulo, São Paulo, Brazil

and more 72 locations

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

Phase 3
Active, not recruiting
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
First Posted Date
2020-12-04
Last Posted Date
2024-11-28
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
51
Registration Number
NCT04654468
Locations
🇨🇳

Tianjin Medical University General Hospital, Tianjin, China

🇨🇳

Guangdong General Hospital, Guangzhou, China

🇨🇳

West China Hospital, Sichuan University, Chengdu, China

and more 2 locations

A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

Phase 3
Active, not recruiting
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
First Posted Date
2020-06-16
Last Posted Date
2024-11-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
204
Registration Number
NCT04434092
Locations
🇵🇱

MTZ Clinical Research Powered by Pratia, Warszawa, Poland

🇲🇽

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, Mexico

🇵🇹

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, Portugal

and more 68 locations

A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Phase 3
Active, not recruiting
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
First Posted Date
2020-06-16
Last Posted Date
2024-11-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
190
Registration Number
NCT04432584
Locations
🇫🇷

Institut Paoli Calmette; Service d'Hématologie Clinique, Marseille, France

🇬🇷

General Hospital of Athens LAIKO, Athens, Greece

🇬🇷

Attikon University General Hospital, Chaidari, Greece

and more 87 locations

Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

Phase 1
Active, not recruiting
Conditions
Paroxysmal Hemoglobinuria, Nocturnal
Interventions
Drug: Crovalimab
Drug: Placebo
First Posted Date
2017-05-17
Last Posted Date
2024-11-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
59
Registration Number
NCT03157635
Locations
🇩🇪

Elblandklinikum Riesa; Klinik fuer Haematologie Onkologie und Gastroenterologie, Riesa, Germany

🇫🇷

Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis, Paris, France

🇫🇷

Centre Hospitalier Lyon Sud, Pierre Benite, France

and more 16 locations
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