|
|
|
|
| LEADER |
01000caa a22002652 4500 |
| 001 |
CTG008090416 |
| 003 |
DE-627 |
| 005 |
20230425165048.0 |
| 007 |
cr uuu---uuuuu |
| 008 |
211222s2022 xx |||||o 00| ||eng c |
| 035 |
|
|
|a (DE-627)CTG008090416
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)EUCTR2021-000621-27-NL
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)RTRX-RE021-201
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)2021-000621-27-ES
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 245 |
1 |
0 |
|a Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.
|b A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK
|
| 264 |
|
1 |
|c 2022
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a Computermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a Online-Ressource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 14-12-2021, Last updated: 2022-11-24
|
| 650 |
|
4 |
|a Medical Condition: Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1Level: LLTClassification code 10082959Term: IgA vasculitisSystem Organ Class: 100000004858 MedDRA version: 20.0Level: PTClassification code 10001843Term: Alport's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1Level: LLTClassification code 10058326Term: Minimal change diseaseSystem Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
|
| 650 |
|
4 |
|a Study Type: Interventional
|
| 650 |
|
4 |
|a Phase: Phase 2
|
| 650 |
|
4 |
|a Recruitment Status: Authorised-recruitment may be ongoing or finished
|
| 650 |
|
4 |
|a 610
|
| 773 |
0 |
8 |
|i Enthalten in
|t WHO International Clinical Trials Registry Platform
|g (2022) vom: 04. Apr.
|
| 773 |
1 |
8 |
|g year:2022
|g day:04
|g month:04
|
| 856 |
4 |
0 |
|u https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000621-27
|z kostenfrei
|3 Volltext
|
| 912 |
|
|
|a GBV_CTG
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 951 |
|
|
|a AR
|
| 952 |
|
|
|j 2022
|b 04
|c 04
|
Klinische Studie