SAR422459 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
301黄斑ジストロフィー4

301. 黄斑ジストロフィー


臨床試験数 : 45 薬物数 : 46 - (DrugBank : 12) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 67
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2010-023111-34-IT
(EUCTR)
22/03/201828/09/2018A Phase I/IIa Study of SAR422459 in Patients With Stargardt's Macular DegenerationA Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients with Stargardt's Macular Degeneration. - na Stargardt Macular Degeneration, also known as Stargardt Macular Dystrophy, fundus flavimaculatus or Stargardt disease.
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: SAR422459
Product Code: Vett Lentiviral con gene ABCA4
INN or Proposed INN: SAR422459
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2United States;France;Netherlands;Italy
2EUCTR2010-023111-34-NL
(EUCTR)
24/02/201604/02/2016A Phase I/IIa Study of SAR422459 in Patients With Stargardt Macular DegenerationA Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients with Stargardt's Macular Degeneration. Stargardt Macular Dystrophy, also known as fundus flavimaculatus or Stargardt disease.
MedDRA version: 18.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: SAR422459
Product Code: Lentiviral vector containing ABCA4 gene
INN or Proposed INN: SAR422459
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
46Phase 1/2France;United States;Netherlands;Italy
3NCT01736592
(ClinicalTrials.gov)
December 14, 201226/11/2012Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular DegenerationAn Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular DegenerationStargardt's DiseaseDrug: Long term follow up in all patients who received SAR422459 in previous study TDU13583SanofiNULLActive, not recruiting6 YearsN/AAll27Phase 1/Phase 2United States;France
4NCT01367444
(ClinicalTrials.gov)
June 8, 20113/6/2011Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular DegenerationA Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular DegenerationStargardt's DiseaseDrug: SAR422459SanofiNULLTerminated6 YearsN/AAll27Phase 1/Phase 2United States;France