Sar422459 (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
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301 | Macular dystrophy | 4 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | EUCTR2010-023111-34-IT (EUCTR) | 22/03/2018 | 28/09/2018 | A Phase I/IIa Study of SAR422459 in Patients With Stargardt's Macular Degeneration | A 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 DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | France;United States;Netherlands;Italy | ||
2 | EUCTR2010-023111-34-NL (EUCTR) | 24/02/2016 | 04/02/2016 | A Phase I/IIa Study of SAR422459 in Patients With Stargardt Macular Degeneration | A 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2a | France;United States;Netherlands;Italy | ||
3 | NCT01736592 (ClinicalTrials.gov) | December 14, 2012 | 26/11/2012 | Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration | An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration | Stargardt's Disease | Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583 | Sanofi | NULL | Active, not recruiting | 6 Years | N/A | All | 27 | Phase 1;Phase 2 | United States;France |
4 | NCT01367444 (ClinicalTrials.gov) | June 8, 2011 | 3/6/2011 | Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration | A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular Degeneration | Stargardt's Disease | Drug: SAR422459 | Sanofi | NULL | Terminated | 6 Years | N/A | All | 27 | Phase 1;Phase 2 | United States;France |