Imiglucerase
- Generic Name
- Imiglucerase
- Brand Names
- Cerezyme
- Drug Type
- Biotech
- CAS Number
- 154248-97-2
- Unique Ingredient Identifier
- Q6U6J48BWY
- Background
Human Beta-glucocerebrosidase or Beta-D-glucosyl-N-acylsphingosine glucohydrolase E.C. 3.2.1.45. 497 residue protein with N-linked carbohydrates, MW=59.3 kD. Alglucerase is prepared by modification of the oligosaccharide chains of human Beta-glucocerebrosidase. The modification alters the sugar residues at the non-reducing ends of the oligosaccharide chains of the glycoprotein so that they are predominantly terminated with mannose residues.
- Indication
For the treatment of Gaucher's disease (deficiency in glucocerebrosidase)
- Associated Conditions
- Gaucher Disease, Type 1, Gaucher Disease, Type III
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3
- Conditions
- Gaucher's Disease Type III
- Interventions
- First Posted Date
- 2022-02-03
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 43
- Registration Number
- NCT05222906
- Locations
- 🇺🇸
Yale University School of Medicine - Investigational Site Number: 8400003, New Haven, Connecticut, United States
🇺🇸University of Iowa - Investigational Site Number: 8400002, Iowa City, Iowa, United States
🇺🇸Texas Oncology - Medical City Dallas Site Number : 8400008, Dallas, Texas, United States
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
- First Posted Date
- 2021-03-09
- Last Posted Date
- 2021-04-05
- Lead Sponsor
- ISU Abxis Co., Ltd.
- Target Recruit Count
- 42
- Registration Number
- NCT04787887
- Locations
- 🇦🇺
Scientia Clinical Research Limited, Randwick, New South Wales, Australia
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ
- First Posted Date
- 2020-12-07
- Last Posted Date
- 2024-01-23
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 12
- Registration Number
- NCT04656600
- Locations
- 🇨🇳
Investigational Site Number : 102, Guangzhou, China
🇨🇳Investigational Site Number : 107, Beijing, China
🇨🇳Investigational Site Number : 101, Beijing, China
Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3
- Conditions
- Gaucher's Disease Type IGaucher's Disease Type III
- Interventions
- First Posted Date
- 2018-04-02
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 57
- Registration Number
- NCT03485677
- Locations
- 🇨🇦
Investigational Site Number : 1240002, Calgary, Alberta, Canada
🇦🇷Investigational Site Number : 0320001, Capital Federal, Buenos Aires, Argentina
🇨🇦Investigational Site Number : 1240003, Vancouver, British Columbia, Canada
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
- Conditions
- Gaucher Disease Type 3Gaucher Disease Type 1
- Interventions
- First Posted Date
- 2016-07-25
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- Genzyme, a Sanofi Company
- Target Recruit Count
- 12
- Registration Number
- NCT02843035
- Locations
- 🇬🇧
Investigational Site Number : 826002, Salford, Manchester, United Kingdom
🇯🇵Investigational Site Number : 392001, Minato-ku, Tokyo, Japan
🇬🇧Investigational Site Number : 826003, Cambridge, Cambridgeshire, United Kingdom
Phase III Study of ISU302 in Patients With Type 1 Gaucher Disease
- First Posted Date
- 2016-05-12
- Last Posted Date
- 2017-07-12
- Lead Sponsor
- ISU Abxis Co., Ltd.
- Target Recruit Count
- 8
- Registration Number
- NCT02770625
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
- First Posted Date
- 2013-06-19
- Last Posted Date
- 2013-06-19
- Lead Sponsor
- ISU Abxis Co., Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT01881633
The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease
- First Posted Date
- 2010-07-14
- Last Posted Date
- 2016-08-23
- Lead Sponsor
- ISU Abxis Co., Ltd.
- Registration Number
- NCT01161914
Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1)
- First Posted Date
- 2010-06-03
- Last Posted Date
- 2015-06-01
- Lead Sponsor
- University Research Foundation for Lysosomal Storage Diseases, Inc.
- Target Recruit Count
- 173
- Registration Number
- NCT01136304
- Locations
- 🇺🇸
Tower Cancer Research Foundation, Beverly Hills, California, United States
🇺🇸Northwest Oncology Hematology Associates PA, Coral Springs, Florida, United States
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
- Conditions
- Gaucher Disease, Type 1
- Interventions
- First Posted Date
- 2009-07-22
- Last Posted Date
- 2016-11-25
- Lead Sponsor
- Genzyme, a Sanofi Company
- Target Recruit Count
- 160
- Registration Number
- NCT00943111
- Locations
- 🇺🇸
Albany Medical Center, Albany, New York, United States
🇺🇸North Shore University Medical Center, Manhasset, New York, United States
🇺🇸University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Drug Development Updates
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