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Clinical trial

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

NCT04782258 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
January 23, 2023
Completion date
August 14, 2028
Enrollment
20 (estimated)
Sites
23

Conditions

As the registry lists them; a condition with its own page is linked.

autosomal recessive polycystic kidney (arpkd)