FLT190 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
19Lysosomal storage disease5

19. Lysosomal storage disease


Clinical trials : 854 Drugs : 716 - (DrugBank : 105) / Drug target genes : 70 - Drug target pathways : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002097-51-AT
(EUCTR)
02/12/202124/03/2021A Fabry Disease Gene Therapy Study (MARVEL 1)A Phase 1/2, Baseline-controlled, Non-randomized, Open-label, Single-ascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease - MARVEL1 Fabry disease
MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: FLT190
Product Code: FLT190
INN or Proposed INN: NA
Other descriptive name: FLT190
Freeline Therapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
15Phase 1;Phase 2United States;France;Denmark;Austria;Norway;Germany;United Kingdom;Switzerland;Italy
2EUCTR2018-002097-51-DK
(EUCTR)
04/12/202008/07/2019A Fabry Disease Gene Therapy StudyA Phase 1/2, Baseline-controlled, Non-randomised, Open-label, Single-ascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease - MARVEL1 Fabry disease
MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: FLT190
Product Code: FLT190
INN or Proposed INN: NA
Other descriptive name: FLT190
Freeline Therapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
12Phase 1;Phase 2United States;France;Spain;Denmark;Norway;Germany;United Kingdom;Italy
3EUCTR2019-004645-32-GB
(EUCTR)
24/03/202031/12/2019A Long-term Follow-up Study of Fabry Disease Subjects Treated with FLT190 (MARVEL 2)A Multicentre, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT190) in Subjects with Fabry Disease - Marvel 2 Fabry disease
MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: FLT190
Product Code: FLT190
INN or Proposed INN: NA
Other descriptive name: FLT190
Freeline Therapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
15Phase 2United States;France;Denmark;Norway;Germany;Italy;United Kingdom
4EUCTR2018-002097-51-DE
(EUCTR)
12/02/202028/02/2019A Fabry Disease Gene Therapy Study (MARVEL 1)A Phase 1/2, Baseline-controlled, Non-randomized, Open-label, Single-ascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease - MARVEL1 Fabry disease
MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: FLT190
Product Code: FLT190
INN or Proposed INN: NA
Other descriptive name: FLT190
Freeline Therapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
15Phase 1;Phase 2United States;France;Denmark;Austria;Norway;Germany;United Kingdom;Switzerland;Italy
5EUCTR2018-002097-51-IT
(EUCTR)
26/06/201919/01/2021A Fabry Disease Gene Therapy Study (MARVEL 1)A Phase 1/2, Baseline-controlled, Non-randomised, Open-label, Singleascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease - MARVEL1 Fabry disease
MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: FLT190
Product Code: [FLT190]
Other descriptive name: FLT190
Freeline Therapeutics LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
12Phase 1;Phase 2France;United States;Denmark;Norway;Germany;United Kingdom;Italy