Lademirsen (SAR339375) ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
218アルポート症候群2

218. アルポート症候群


臨床試験数 : 30 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004394-10-DE
(EUCTR)
30/06/202009/12/2019Study of lademirsen (SAR339375) in patients with Alport SyndromeA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Spain;Australia;Germany;United Kingdom;China
2NCT02855268
(ClinicalTrials.gov)
November 2, 201928/7/2016Study of Lademirsen (SAR339375) in Patients With Alport SyndromeA 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 SyndromeAlport's SyndromeDrug: lademirsen (SAR339375);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 Years55 YearsAll43Phase 2United States;Australia;China;France;Germany;Spain;United Kingdom;Canada