Botaretigene sparoparvovec ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
90Retinitis pigmentosa4

90. Retinitis pigmentosa


Clinical trials : 130 Drugs : 180 - (DrugBank : 41) / Drug target genes : 49 - Drug target pathways : 109
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002255-37-NL
(EUCTR)
14/03/202222/10/2021Long Term Follow-Up study of Gene Therapy Trial for Patients with Retinitis Pigmentosa (progressive reduction in vision) due to a gene defect on Chromosome X.Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene - Long Term Follow-Up study of Gene Therapy Trial for Patients with Retinitis Pigmentosa: RPGR X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-hRKp.RPGR
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-hRKp.RPGR
MeiraGTx UK II LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3Switzerland;United Kingdom;France;United States;Spain;Ireland;Israel;Italy;Canada;Belgium;Denmark;Netherlands;Germany
2EUCTR2020-002873-88-NL
(EUCTR)
14/03/202222/10/2021Gene Therapy Trial for Patients with Retinitis Pigmentosa (progressive reduction in vision) due to a gene defect on Chromosome X.Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene - Gene Therapy Trial for Patients with Retinitis Pigmentosa: RPGR X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-hRKp.RPGR
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-hRKp.RPGR
MeiraGTx UK II LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3United States;Spain;Ireland;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Netherlands;Germany
3EUCTR2020-002873-88-DK
(EUCTR)
01/03/202208/11/2021Gene Therapy Trial for Patients with Retinitis Pigmentosa (progressive reduction in vision) due to a gene defect on Chromosome X.Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene - Gene Therapy Trial for Patients with Retinitis Pigmentosa: RPGR X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-HRKP.RPGR
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-HRKP.RPGR
MeiraGTx UK II LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3United States;Spain;Ireland;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands
4EUCTR2020-002255-37-DK
(EUCTR)
01/03/202208/11/2021Long Term Follow-Up study of Gene Therapy Trial for Patients with Retinitis Pigmentosa (progressive reduction in vision) due to a gene defect on Chromosome X.Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene - Long Term Follow-Up study of Gene Therapy Trial for Patients with Retinitis Pigmentosa: RPGR X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-HRKP.RPGR
Product Name: AAV5-hRKp.RPGR
INN or Proposed INN: botaretigene sparoparvovec
Other descriptive name: AAV5-HRKP.RPGR
MeiraGTx UK II LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3United States;Spain;Ireland;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands