CLINICAL TRIALS PROFILE FOR TALIGLUCERASE ALFA
✉ Email this page to a colleague
All Clinical Trials for Taliglucerase Alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00712348 ↗ | Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase | Completed | Pfizer | Phase 3 | 2008-12-01 | This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy. |
| NCT00712348 ↗ | Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase | Completed | Protalix | Phase 3 | 2008-12-01 | This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy. |
| NCT01132690 ↗ | A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease | Completed | Pfizer | Phase 4 | 2010-08-01 | This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available. |
| NCT01132690 ↗ | A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease | Completed | Protalix | Phase 4 | 2010-08-01 | This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available. |
| NCT01411228 ↗ | A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease | Completed | Pfizer | Phase 3 | 2011-09-01 | A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa). |
| NCT01411228 ↗ | A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease | Completed | Protalix | Phase 3 | 2011-09-01 | A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa). |
| NCT01422187 ↗ | A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease | Completed | Pfizer | Phase 3 | 2011-08-01 | This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Taliglucerase Alfa
Condition Name
Clinical Trial Locations for Taliglucerase Alfa
Trials by Country
Clinical Trial Progress for Taliglucerase Alfa
Clinical Trial Phase
Clinical Trial Sponsors for Taliglucerase Alfa
Sponsor Name
