You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR VELAGLUCERASE ALFA


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for velaglucerase alfa

Trial ID Title Status Sponsor Phase Start Date 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 2004-09-13 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 1969-12-31 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 2013-03-13 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 2013-03-13 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 Withdrawn Texas Scottish Rite Hospital for Children Phase 4 2015-07-01 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.
NCT02528617 ↗ The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher Disease Withdrawn Baylor Research Institute Phase 4 2015-07-01 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 >Phase >Start Date >Summary

Clinical Trial Conditions for velaglucerase alfa

Condition Name

Condition Name for velaglucerase alfa
Intervention Trials
Gaucher Disease 4
Gaucher Disease, Type 1 2
Gaucher Disease Type 1 1
Gaucher Disease Type 3 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for velaglucerase alfa
Intervention Trials
Gaucher Disease 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for velaglucerase alfa

Trials by Country

Trials by Country for velaglucerase alfa
Location Trials
United States 26
Japan 3
Israel 3
Romania 1
United Kingdom 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for velaglucerase alfa
Location Trials
North Carolina 2
Illinois 2
Georgia 2
California 2
Virginia 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for velaglucerase alfa

Clinical Trial Phase

Clinical Trial Phase for velaglucerase alfa
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2/Phase 3 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for velaglucerase alfa
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 2
Active, not recruiting 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for velaglucerase alfa

Sponsor Name

Sponsor Name for velaglucerase alfa
Sponsor Trials
Shire 5
Shaare Zedek Medical Center 2
AVROBIO 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for velaglucerase alfa
Sponsor Trials
Industry 8
Other 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.