Last updated on May 2019

Study of Pharmacokinetics Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

Brief description of study

The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages 28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. This trial will utilize age groups: Group 1 includes patients 12y to <18y, Group 2 includes patients 6y to <12y, Group 3 includes patients 2y to <6y, and Group 4 includes patients 28days to <2y.

Clinical Study Identifier: NCT03491215

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Novartis Investigative Site

Parkville, Australia
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Recruitment Status: Open

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