218. Alport syndrome Clinical trials / Disease details
Clinical trials : 30 / Drugs : 36 - (DrugBank : 15) / Drug target genes : 8 - Drug target pathways : 46
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004394-10-DE (EUCTR) | 30/06/2020 | 09/12/2019 | Study of lademirsen (SAR339375) in patients with Alport Syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients with Alport Syndrome - HERA | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Lademirsen Product Code: SAR339375 Other descriptive name: RG-012 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Australia;Germany;United Kingdom;China | ||
| 2 | NCT03373786 (ClinicalTrials.gov) | December 22, 2017 | 22/10/2017 | A Study of RG-012 in Subjects With Alport Syndrome | A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection, Including Its Effect on Renal microRNA-21, in Subjects With Alport Syndrome | Alport Syndrome | Drug: RG012 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 65 Years | All | 4 | Phase 1 | United States |
| 3 | EUCTR2016-002181-32-GB (EUCTR) | 07/12/2016 | 08/09/2016 | A research study to evaluate the safety and effectiveness of RG-012 as a treatment for patients with Alport syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Patients with Alport Syndrome - A Phase 2 Study to Evaluate Weekly RG012 Injections in Alport Syndrome | Alport syndrome is an inherited form of kidney disease caused by mutations in genes coding for the capillary basement membrane collagen IV;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: RG-012 | Regulus Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Australia;Germany;United Kingdom |