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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

February 21, 2019

Primary Completion Date

March 11, 2021

Study Completion Date

February 2, 2023

Conditions
Acute Graft Versus Host Disease
Interventions
DRUG

Ruxolitinib

All enrolled pediatric participants received ruxolitinib as a 5 mg tablet (adult and adolescent formulation) or an oral pediatric formulation (administered as oral solution or capsule dispersed in liquid).

Trial Locations (19)

1020

Novartis Investigative Site, Laken

9000

Novartis Investigative Site, Ghent

16147

Novartis Investigative Site, Genova

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

35022

Novartis Investigative Site, Rennes

44093

Novartis Investigative Site, Nantes

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

59000

Novartis Investigative Site, Lille

75015

Novartis Investigative Site, Paris

75019

Novartis Investigative Site, Paris

H3T 1C5

Novartis Investigative Site, Montreal

DK-2100

Novartis Investigative Site, Copenhagen

00165

Novartis Investigative Site, Roma

466 8560

Novartis Investigative Site, Nagoya

330 8777

Novartis Investigative Site, Saitama

03080

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY