9 completed, 1 no longer available, 1 withdrawn. 6 Phase 3, 2 Phase 4, 1 Not applicable, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Withdrawn 1 |
| Phase 4 | 2 | Completed 2 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Withdrawn 1 |
Follow taliglucerase alfa: new trials by email Literature Review of taliglucerase alfa trials Research Report on taliglucerase alfa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Efficacy and Safety Study of AVR-RD-02 Compared to Enzyme Replacement Therapy for Treatment of Gaucher Disease Type 3 Gene therapy, Enzyme Replacement Agent - Gaucher Disease, Type 3 | Phase 2 / Phase 3 | Withdrawn | AVROBIO | 2023-10-01 | 2023-08-09 | |
| A Multicenter, Safety and Efficacy Study of Taliglucerase Alfa in Subjects With Type 3 Gaucher Disease Elelyso - Gaucher Disease, Type 3 | Phase 4 | Completed | Ari Zimran | 14 | 2020-11-20 | 2024-12-17 |
| Assessing the Impact of Elelyso on Bone Involvement Currently Treated With Other ERTs quantitative chemical shift imaging (QCSI), Elelyso - Gaucher Disease, Type 1 | Not applicable | Completed | Shaare Zedek Medical Center | 30 | 2017-01-01 | 2022-10-28 |
| A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease Taliglucerase alfa - Gaucher Disease | Phase 3 | Completed | Pfizer | 15 | 2011-09-01 | 2018-09-07 |
| A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease Taliglucerase alfa - Gaucher Disease | Phase 3 | Completed | Pfizer | 19 | 2011-08-01 | 2023-04-19 |
| A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease Taliglucerase alfa - Gaucher Disease | Phase 4 | Completed | Pfizer | 11 | 2010-08-01 | 2018-10-05 |
| Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Taliglucerase alfa - Gaucher Disease | Phase 3 | Completed | Pfizer | 31 | 2008-12-01 | 2018-10-04 |
| Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial Taliglucerase alfa - Gaucher Disease | Phase 3 | Completed | Pfizer | 45 | 2008-06-01 | 2018-10-04 |
| A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease Plant cell expressed recombinant glucocerebrosidase (prGCD) - Gaucher Disease | Phase 3 | Completed | Pfizer | 32 | 2007-08-01 | 2018-10-04 |
| Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD) Human Glucocerebrosidase (prGCD) - Gaucher Disease | Phase 1 | Completed | Protalix | 6 | 2005-11-01 | 2006-12-05 |
| Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease Plant cell expressed recombinant glucocerebrosidase (prGCD) - Gaucher Disease | No longer available | Pfizer | 2018-09-07 |
Gaucher Disease (11) · Anemia (1) · Hepatomegaly (1) · Lysosomal Storage Diseases (1) · Splenomegaly (1) · Thrombocytopenia (1)
Pfizer (7) · AVROBIO (1) · Ari Zimran (1) · Protalix (1) · Shaare Zedek Medical Center (1)
Israel (7) · South Africa (4) · United States (4) · Canada (3) · Spain (3) · United Kingdom (3) · Australia (2) · Chile (2) · Paraguay (2) · India (1) · Italy (1) · Turkey (Türkiye) (1)
Ari Zimran, MD (1) · Ari Zimran, Prof. (1) · Eithan Galun, MD (1) · Milena Veselinovic, MD, PhD (1)
PMID 26053270, PMID 18729283, PMID 19277123, PMID 21900191, PMID 23199589, PMID 24924293, PMID 24950666, PMID 25453586, PMID 27102949, PMID 27174694, PMID 27499018, PMID 27839981, PMID 30066229