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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR VELAGLUCERASE ALFA

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Clinical Trials for Velaglucerase Alfa

Trial ID Title Status Sponsor Phase Summary
NCT00391625 Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT) Completed Shire Phase 1/Phase 2 Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this study is to evaluate the long term safety of enzyme replacement therapy with DRX008A (VPRIV®, GA-GCB; velaglucerase alfa) in patients with type 1 Gaucher disease.
NCT00954460 Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease Approved for marketing Shire N/A Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this treatment protocol is to observe the safety of velaglucerase alfa in patients with type 1 Gaucher disease who are either treatment naive (newly diagnosed) or who are currently being treated with the Enzyme Replacement Therapy (ERT) imiglucerase.
NCT01842841 Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease Completed Quintiles, Inc. Phase 3 Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1 Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher disease present with acute neurological deterioration, which leads to early death. Those with Type 3 disease typically display a more sub-acute neurological course, with later onset and slower progression. The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa. Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type 1 Gaucher disease.
NCT01842841 Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease Completed Shire Phase 3 Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1 Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher disease present with acute neurological deterioration, which leads to early death. Those with Type 3 disease typically display a more sub-acute neurological course, with later onset and slower progression. The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa. Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type 1 Gaucher disease.
NCT02528617 The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher Disease Recruiting Texas Scottish Rite Hospital for Children Phase 4 The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural history and neurological status of children with Type 3 Gaucher Disease will be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Velaglucerase Alfa

Condition Name

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

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

Trials by Country

Trials by Country for Velaglucerase Alfa
Location Trials
United States 21
Israel 3
Japan 3
United Kingdom 1
Serbia 1
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Trials by US State

Trials by US State for Velaglucerase Alfa
Location Trials
California 2
New York 2
Iowa 1
Maryland 1
Massachusetts 1
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Clinical Trial Progress for Velaglucerase Alfa

Clinical Trial Phase

Clinical Trial Phase for Velaglucerase Alfa
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Velaglucerase Alfa
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Approved for marketing 1
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Clinical Trial Sponsors for Velaglucerase Alfa

Sponsor Name

Sponsor Name for Velaglucerase Alfa
Sponsor Trials
Shire 4
Quintiles, Inc. 1
Shaare Zedek Medical Center 1
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Sponsor Type

Sponsor Type for Velaglucerase Alfa
Sponsor Trials
Industry 5
Other 3
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Serving hundreds of leading biopharmaceutical companies globally:

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