19. ライソゾーム病 Lysosomal storage disease Clinical trials / Disease details


臨床試験数 : 854 薬物数 : 727 - (DrugBank : 105) / 標的遺伝子数 : 69 - 標的パスウェイ数 : 190

  
29 trials found
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PhaseCountries
1NCT04429984
(ClinicalTrials.gov)
July 28, 20219/6/2020Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in IndiaA Post Marketing Surveillance (PMS) Study for VPRIV (Velaglucerase Alfa) in IndiaGaucher DiseaseDrug: Velaglucerase alfa (VPRIV)ShireNULLRecruitingN/AN/AAll35India
2NCT04718779
(ClinicalTrials.gov)
April 22, 202120/1/2021A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction TherapyA Multicenter, Interventional, Retrospective and Prospective Study of Enzyme Replacement Therapy (VPRIV) Clinical Outcomes and Safety in Gaucher Disease Type 1 Patients Previously Treated With Substrate Reduction TherapyGaucher DiseaseDrug: Velaglucerase alfaTakedaNULLRecruiting18 YearsN/AAll20Phase 4United States
3NCT03702361
(ClinicalTrials.gov)
September 4, 20186/8/2018Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher DiseaseRapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher Disease: An Investigator-initiated StudyPrimary DiseaseDrug: VPRIVShaare Zedek Medical CenterNULLCompleted6 Years75 YearsAll15Phase 4Israel
4EUCTR2015-001578-17-IT
(EUCTR)
18/07/201804/11/2020An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseAn Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase alfa on Bone-related Pathology inTreatment-naïve Patients with Type 1 Gaucher Disease - SHP-GCB-402 Gaucher Disease
MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: VPRIV - 400 U - POLVERE PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO
Product Name: Velaglucerase alfa
Product Code: [-]
INN or Proposed INN: velaglucerasi alfa
Other descriptive name: GLUCOCEREBROSIDASE UMANO GENE-ATTIVATO
SHIRE HUMAN GENETIC THERAPIES, INCNULLNot RecruitingFemale: yes
Male: yes
40Phase 4United States;Spain;Israel;Germany;United Kingdom;Italy
5EUCTR2015-001578-17-DE
(EUCTR)
12/09/201622/12/2015An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseAn Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase alfa on Bone-related Pathology inTreatment-naïve Patients with Type 1 Gaucher Disease Gaucher Disease
MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: VPRIV 400 Units powder for solution of infusion
INN or Proposed INN: VELAGLUCERASE ALFA
Other descriptive name: Gene activated human glucocerebrosidase, velaglucerase alfa
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4United States;Spain;Turkey;Israel;Germany;Italy;United Kingdom;India
6NCT02574286
(ClinicalTrials.gov)
June 29, 20169/10/2015Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher DiseaseAn Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect of Treatment With Velaglucerase Alfa on Bone-related Pathology in Treatment-naïve Patients With Type 1 Gaucher DiseaseGaucher DiseaseDrug: Velaglucerase alfa;Dietary Supplement: Vitamin DShireNULLCompleted18 Years70 YearsAll21Phase 4United States;Israel;Spain;United Kingdom
7EUCTR2015-001578-17-ES
(EUCTR)
25/02/201613/01/2016An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseAn Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect of Treatment with Velaglucerase alfa on Bone-related Pathology in Treatment-naïve Patients with Type 1 Gaucher Disease Gaucher Disease
MedDRA version: 18.1;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: VPRIV 400 Units powder for solution of infusion
INN or Proposed INN: VELAGLUCERASE ALFA
Other descriptive name: Gene activated human glucocerebrosidase, velaglucerase alfa
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 4United States;Canada;Spain;Israel;Germany;Italy;United Kingdom
8EUCTR2015-001578-17-GB
(EUCTR)
17/02/201621/12/2015An Open-Label, Phase IV Study of Velaglucerase alfa on Bone Related Pathology in Adult, Treatment-Naïve Patients with Type 1 Gaucher DiseaseAn Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect ofTreatment with Velaglucerase alfa on Bone-related Pathology inTreatment-naïve Patients with Type 1 Gaucher Disease Gaucher Disease
MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: VPRIV 400 Units powder for solution of infusion
INN or Proposed INN: VELAGLUCERASE ALFA
Other descriptive name: Gene activated human glucocerebrosidase, velaglucerase alfa
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
19Phase 4United States;Canada;Spain;Israel;Germany;United Kingdom
9NCT04120506
(ClinicalTrials.gov)
January 10, 201610/8/2018Long Term Impact of Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV)Long Term Impact of Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Adult Patients With Type 1 Gaucher Disease, Previously on a Stable Dose of VPRIV for at Least 3 Months: an Extension of the Investigator-initiated StudyGaucher Disease, Type 1Drug: VPRIVShaare Zedek Medical CenterShireActive, not recruiting6 Years75 YearsAll15Phase 4NULL
10NCT02528617
(ClinicalTrials.gov)
July 201528/7/2015The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher DiseaseThe Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher DiseaseGaucher Disease Type 1;Gaucher Disease Type 3Drug: Velaglucerase alfaBaylor Research InstituteTexas Scottish Rite Hospital for ChildrenWithdrawn4 Years14 YearsAll0Phase 4United States
11NCT01842841
(ClinicalTrials.gov)
March 201311/4/2013Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher DiseaseA Multicenter, Open-label Extension Study of Velaglucerase Alfa Enzyme Replacement Therapy in Japanese Patients With Gaucher DiseaseGaucher DiseaseDrug: velaglucerase alfaShireQuintiles, Inc.Completed2 YearsN/AAll5Phase 3Japan
12NCT01685216
(ClinicalTrials.gov)
September 201210/9/2012Efficacy and Safety Study of Velaglucerase Alfa in Children and Adolescents With Type 3 Gaucher DiseaseA Multi-center, Open-label, Efficacy and Safety Study of Velaglucerase Alfa Enzyme Replacement Therapy in Children and Adolescents With Type 3 Gaucher DiseaseGaucher Disease, Type 3Biological: velaglucerase alfaShireNULLCompleted2 Years17 YearsAll7Phase 1/Phase 2Egypt;India;Tunisia
13NCT01614574
(ClinicalTrials.gov)
March 2, 20126/6/2012Study of Velaglucerase Alfa Enzyme Replacement Therapy in Japanese Patients With Gaucher DiseaseA Multicenter, Open-Label Study of Velaglucerase Alfa Enzyme Replacement Therapy in Japanese Patients With Gaucher DiseaseGaucher DiseaseBiological: velaglucerase alfaShireNULLCompleted2 YearsN/AAll6Phase 3Japan
14NCT00954460
(ClinicalTrials.gov)
October 20095/8/2009Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher DiseaseMulticenter Open-Label Treatment Protocol to Observe the Safety of Gene-Activated™ Human Glucocerebrosidase (GA-GCB, Velaglucerase Alfa) ERT in Newly Diagnosed or Previously Treated (With Imiglucerase) Patients With Type 1 Gaucher DiseaseGaucher Disease, Type 1Drug: velaglucerase alfaShireNULLApproved for marketing3 YearsN/AAllUnited States
15EUCTR2008-001965-27-ES
(EUCTR)
23/12/200817/09/2008Estudio de extensión abierto de terapia de sustitución enzimática con glucocerebrosidasa humana activada genéticamente® (GA-GCB) en pacientes con enfermedad de Gaucher de tipo IAn Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher DiseaseEstudio de extensión abierto de terapia de sustitución enzimática con glucocerebrosidasa humana activada genéticamente® (GA-GCB) en pacientes con enfermedad de Gaucher de tipo IAn Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease Enfermedad de Gaucher de tipo IType I Gaucher disease
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: Gene activated human glucocerebrosidase
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
102Spain;United Kingdom
16EUCTR2008-001965-27-GB
(EUCTR)
29/10/200815/07/2008An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher DiseaseAn Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease Type I Gaucher disease
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase 400U/vial
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: Gene activated human glucocerebrosidase, velaglucerase alfa
Product Name: Gene-Activated Human Glucocerebrosidase 200U/vial
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: Gene activated human glucocerebrosidase, velaglucerase alfa
Shire Human Genetic Therapies, Inc.NULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;United Kingdom
17NCT00635427
(ClinicalTrials.gov)
May 20086/3/2008An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher DiseaseAn Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher DiseaseGaucher Disease, Type 1Biological: VPRIV®ShireNULLCompleted2 YearsN/AAll95Phase 3United States;Argentina;India;Israel;Korea, Republic of;Paraguay;Poland;Russian Federation;Spain;Tunisia;United Kingdom
18EUCTR2006-006304-11-IT
(EUCTR)
14/04/200804/08/2008A Multicenter Open-Label Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease Previously Treated with Imiglucerase - NDA Multicenter Open-Label Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease Previously Treated with Imiglucerase - ND Patients with type 1 Gaucher disease who previously received imiglucerase
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase
Product Code: GA-GCB
SHIRE HUMAN GENETIC THERAPIES, INC.NULLNot RecruitingFemale: yes
Male: yes
40United Kingdom;Spain;Italy
19EUCTR2007-002840-21-IT
(EUCTR)
25/02/200815/04/2008A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher Disease - GCB039A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher Disease - GCB039 Patients with Gaucher disease of type 1
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene Activated Human Glucocerebrosidase
Product Code: GA-GCB
Product Name: imiglucerasi
INN or Proposed INN: Imiglucerase
SHIRE HUMAN GENETIC THERAPIES, INC.NULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Spain;Italy
20NCT00553631
(ClinicalTrials.gov)
January 20081/11/2007Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared With Imiglucerase in Patients With Type I Gaucher DiseaseGaucher Disease, Type 1Biological: velaglucerase alfa;Biological: imigluceraseShireNULLCompleted2 YearsN/AAll34Phase 3United States;Argentina;India;Israel;Paraguay;Russian Federation;Spain;Tunisia;United Kingdom
21EUCTR2007-002840-21-GB
(EUCTR)
29/11/200711/10/2007A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher Disease - HGT-GCB-039A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher Disease - HGT-GCB-039 Type I Gaucher disease
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene Activated Human glucocerebrosidase
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: Gene activated human glucocerebrosidase
Trade Name: Cerezyme
Product Name: Cerezyme
INN or Proposed INN: IMIGLUCERASE
Trade Name: Cerezyme
Product Name: Cerezyme
INN or Proposed INN: IMIGLUCERASE
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32United Kingdom;Spain;Italy
22EUCTR2007-002840-21-ES
(EUCTR)
30/10/200718/07/2007A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher DiseaseEstudio multicéntrico, aleatorizado, a doble ciego, en grupos paralelos sobre la terapia de reemplazo enzimático con Gene-Activated® glucocerebrosidasa humana (GA-GCB) en comparación con imiglucerasa en pacientes con enfermedad de Gaucher de tipo 1 - GCB039A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher DiseaseEstudio multicéntrico, aleatorizado, a doble ciego, en grupos paralelos sobre la terapia de reemplazo enzimático con Gene-Activated® glucocerebrosidasa humana (GA-GCB) en comparación con imiglucerasa en pacientes con enfermedad de Gaucher de tipo 1 - GCB039 Type I Gaucher diseaseEnfermedad de Gaucher tipo 1
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene Activated Human glucocerebrosidase
Product Code: GA-GCB
Other descriptive name: Gene activated human glucocerebrosidase
Trade Name: Cerezyme
INN or Proposed INN: IMIGLUCERASE
Shire Human Genetic Therapies IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32United Kingdom;Spain;Italy
23EUCTR2006-006304-11-ES
(EUCTR)
27/08/200704/03/2010A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase.Estudio abierto multicéntrico sobre la terapia de sustitución enzimática con glucocerebrosidasa humana genéticamente activada (Gene-Activated®, GA-GCB) en pacientes con enfermedad de Gaucher de tipo 1 previamente tratados con imiglucerasa - TKT034A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase.Estudio abierto multicéntrico sobre la terapia de sustitución enzimática con glucocerebrosidasa humana genéticamente activada (Gene-Activated®, GA-GCB) en pacientes con enfermedad de Gaucher de tipo 1 previamente tratados con imiglucerasa - TKT034 Type I Gaucher DiseaseEnfermedad de Gaucher de Tipo I
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase
Product Code: GA-GCB
Other descriptive name: Gene activated human glucocerebrosidase
Shire Human Genetic Therapies IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40United Kingdom;Spain;Italy
24NCT00478647
(ClinicalTrials.gov)
July 25, 200723/5/2007Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With ImigluceraseA Multicenter Open-Label Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher Disease Previously Treated With ImigluceraseGaucher DiseaseBiological: GA-GCB (velaglucerase alfa)ShireNULLCompleted2 YearsN/AAll40Phase 2/Phase 3United States;Israel;Poland;Spain;United Kingdom
25EUCTR2006-006304-11-GB
(EUCTR)
03/07/200712/02/2007A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase - TKT034A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase - TKT034 Type I Gaucher Disease
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase
Product Code: GA-GCB
Other descriptive name: Gene activated human glucocerebrosidase
Shire Human Genetic Therapies IncNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Germany;Italy;United Kingdom
26NCT00430625
(ClinicalTrials.gov)
February 15, 20071/2/2007A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher DiseaseA Multicenter, Randomized, Double-Blind, Parallel Group, Two-Dose Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher DiseaseGaucher Disease, Type 1Biological: VPRIV ®,ShireNULLCompleted2 YearsN/AAll25Phase 3Argentina;Israel;Paraguay;Russian Federation;Tunisia;United States
27NCT00391625
(ClinicalTrials.gov)
February 200520/10/2006Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT)An Open-Label Extension of Study TKT025 Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A Enzyme Replacement TherapyGaucher DiseaseDrug: GA-GCBShireNULLCompleted18 YearsN/AAll10Phase 1/Phase 2Israel;Romania;Serbia;Former Serbia and Montenegro
28EUCTR2012-003427-38-Outside-EU/EEA
(EUCTR)
07/04/2016Efficacy and Safety Study of Velaglucerase Alfa in Children and Adolescents With Type 3 Gaucher DiseaseA Multi-center, Open-label, Efficacy and Safety Study of Velaglucerase Alfa Enzyme Replacement Therapy in Children and Adolescents With Type 3 Gaucher Disease Type 3 Gaucher disease
MedDRA version: 18.1;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: VPRIV
Product Name: Gene-Activated Human Glucocerebrosidase 400U/vial
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: VELAGLUCERASE ALFA
Shire Human Genetic TherapiesNULLNAFemale: yes
Male: yes
6Tunisia;Egypt;India
29EUCTR2006-006304-11-DE
(EUCTR)
02/11/2007A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase. - TKT034A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase. - TKT034 Type I Gaucher Disease
MedDRA version: 9.1;Level: LLT;Classification code 10018048;Term: Gaucher's disease
Product Name: Gene-Activated Human Glucocerebrosidase
Product Code: GA-GCB
INN or Proposed INN: velaglucerase alfa
Other descriptive name: Gene activated human glucocerebrosidase
Shire Human Genetic Therapies IncNULLNot RecruitingFemale: yes
Male: yes
40Phase 2;Phase 3Spain;Germany;Italy;United Kingdom