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Generated: July 18, 2019

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CLINICAL TRIALS PROFILE FOR TALIGLUCERASE ALFA

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Clinical Trials for Taliglucerase Alfa

Trial ID Title Status Sponsor Phase Summary
NCT00712348 Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase Completed Protalix Phase 3 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 Protalix Phase 4 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 Protalix Phase 3 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 Protalix Phase 3 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.
NCT03021941 Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease Not yet recruiting Pfizer Phase 4 In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT) for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease. The recommended dosage for treatment-naïve adult and pediatric subjects 4 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. As a postmarketing commitment, the Sponsor agreed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of Elelyso (taliglucerase alfa) in pediatric subjects with Type 1 Gaucher Disease. in at least 5 subjects with body weight less than 15 kg; at least 5 subjects with body weight 15 to less than 20 kg; and at least 5 subjects with body weight of 20-25 kg with Type 1 Gaucher disease dosed at 60 units/kg every other week. When applicable, PD measurements for children enrolled in the PK study may be obtained through the taliglucerase alfa registry (PMR 1895-5) and will include organ volumes (spleen and liver), hematological values (hemoglobin and platelets) as well as growth (height and weight) data. Safety data, including any serious hypersensitivity reactions, such as anaphylaxis, as well as changes in antibody status (ie, detection and titers of binding and neutralizing antibodies, and detection of IgE antibodies), will also be collected through the taliglucerase alfa registry.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Taliglucerase Alfa

Condition Name

Condition Name for Taliglucerase Alfa
Intervention Trials
Gaucher Disease 4
Type 1 Gaucher Disease 1
Gaucher Disease, Type 3 1
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Condition MeSH

Condition MeSH for Taliglucerase Alfa
Intervention Trials
Gaucher Disease 6
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Clinical Trial Locations for Taliglucerase Alfa

Trials by Country

Trials by Country for Taliglucerase Alfa
Location Trials
Israel 4
United States 3
Paraguay 2
South Africa 2
Turkey 1
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Trials by US State

Trials by US State for Taliglucerase Alfa
Location Trials
New York 1
Georgia 1
Florida 1
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Clinical Trial Progress for Taliglucerase Alfa

Clinical Trial Phase

Clinical Trial Phase for Taliglucerase Alfa
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Taliglucerase Alfa
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 2
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Clinical Trial Sponsors for Taliglucerase Alfa

Sponsor Name

Sponsor Name for Taliglucerase Alfa
Sponsor Trials
Protalix 4
Pfizer 2
Ari Zimran 1
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Sponsor Type

Sponsor Type for Taliglucerase Alfa
Sponsor Trials
Industry 6
Other 1
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