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Gaucher Disease clinical trials

View clinical trials related to Gaucher Disease.

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NCT ID: NCT01132690 Completed - Gaucher Disease Clinical Trials

A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Start date: August 2010
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01074944 Completed - Gaucher Disease Clinical Trials

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective is to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) is administered QD and BID in patients with Gaucher disease type 1 who have demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

NCT ID: NCT00962260 No longer available - Gaucher Disease Clinical Trials

Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.

NCT ID: NCT00954460 Approved for marketing - Clinical trials for Gaucher Disease, Type 1

Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease

Start date: n/a
Phase:
Study type: Expanded Access

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.

NCT ID: NCT00943111 Active, not recruiting - Clinical trials for Gaucher Disease, Type 1

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)

ENCORE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

This Phase 3 study is designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who have reached therapeutic goals with enzyme replacement therapy (ERT).

NCT ID: NCT00891202 Active, not recruiting - Clinical trials for Gaucher Disease, Type 1

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE)

Start date: November 2009
Phase: Phase 3
Study type: Interventional

This Phase 3 study is designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease Type 1.

NCT ID: NCT00875160 Terminated - Clinical trials for Type 1 Gaucher Disease

A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101

Start date: April 2009
Phase: Phase 1
Study type: Interventional

This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth. The study is being offered to adult patients with type 1 Gaucher disease who are currently receiving a stable dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will not be receiving ERT (up to 35 days). The study consists of a screening period (~14 days), a treatment period (12 days) and a follow-up period (7 days after last dose). At two points in the study, subjects will be housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary blood draws.

NCT ID: NCT00813865 Completed - Gaucher Disease Clinical Trials

A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients

Start date: May 11, 2009
Phase: Phase 2
Study type: Interventional

This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.

NCT ID: NCT00795197 Withdrawn - Clinical trials for Gaucher Disease, Type 1

A Screening Study Evaluating Disease Status of Gaucher Type I Patients

Start date: December 2008
Phase: N/A
Study type: Observational

A screening study to identify and characterize the disease status of patients with Gaucher Type 1 disease for potential inclusion in a subsequent phase 3 clinical study.

NCT ID: NCT00712348 Completed - Gaucher Disease Clinical Trials

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Start date: December 2008
Phase: Phase 3
Study type: Interventional

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.