Trial intelligence / Profile preview

Phase 3b Open-label Tolvaptan Trial in Pediatric ARPKD

2023-508218-41-00Phase 3Authorised

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Start
May 2024
Modality
Small Molecules
Countries
6
01

Overview

Phase 3, open-label, single-arm trial of tolvaptan in autosomal recessive polycystic kidney disease (ARPKD), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Safety assessments, Serum transaminase elevations and 1 more. Planned start May 2024; status: authorised.

02

Drugs

tolvaptan
03

Conditions

autosomal recessive polycystic kidney disease (ARPKD)

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