19. Lysosomal storage disease Clinical trials / Disease details


Clinical trials : 854 Drugs : 716 - (DrugBank : 105) / Drug target genes : 70 - Drug target pathways : 191

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-005544-18-ES
(EUCTR)
29/04/201516/02/2015Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry PatientsA Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry Patients Fabry disease
MedDRA version: 18.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Protalix Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18United States;Paraguay;Spain;United Kingdom
2EUCTR2013-002554-78-ES
(EUCTR)
26/11/201320/09/2013An Extension of the PB102F01 study: A clinical study in patients with Fabry disease to assess the safety, tolerability, and the body processing of the medication PRX102, which will be given as an infusion.An Extension of Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 38 Weeks (9 Months) to Adult Fabry Patients Fabry disease
MedDRA version: 14.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Protalix Ltd.NULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2United States;Serbia;Paraguay;Spain;Australia;Israel;United Kingdom
3EUCTR2012-004786-40-ES
(EUCTR)
13/11/201305/09/2013Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion to Adult Fabry PatientsA Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients Fabry disease
MedDRA version: 16.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Product Name: PRX102
Product Code: PRX102
INN or Proposed INN: PRX102
Protalix Ltd.NULLNot RecruitingFemale: yes
Male: yes
18Phase 1/2United States;Serbia;Paraguay;Argentina;Spain;Australia;Israel;United Kingdom
4EUCTR2013-002554-78-GB
(EUCTR)
29/08/201309/09/2013An Extension of the PB-102-F01 study: A clinical study in patients with Fabry disease to assess the safety, tolerability, and the body processing of the medication PRX102, which will be given as an infusion.An Extension of Phase 1/2, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 38 Weeks (9 Months) to Adult Fabry Patients - PB-102-F02: Extension of the PB-102-F01 study (PRX-102 for ERT in Fabry Disease) Fabry disease
MedDRA version: 16.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: PRX-102
Product Code: PRX-102
INN or Proposed INN: PRX-102
Protalix Ltd.NULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2United States;Paraguay;Argentina;Spain;Australia;Israel;Chile;United Kingdom