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Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
Sponsor: Amgen
Summary
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Official title: A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-10-22
Completion Date
2028-09-26
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Avacopan
Oral administration
Locations (30)
Emory University
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Minnesota Masonic Childrens Hospital Discovery Clinic
Minneapolis, Minnesota, United States
Cohen Children Medical Center
Lake Success, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Charlotte, North Carolina, United States
Akron Childrens Hospital
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Childrens Hospital
Houston, Texas, United States
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium
Alberta Childrens Hospital
Calgary, Alberta, Canada
Stollery Childrens Hospital
Edmonton, Alberta, Canada
CHU Sainte Justine
Montreal, Quebec, Canada
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, France
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, France
Hopital Necker Enfants Malades
Paris, France
Hopital Necker
Paris, France
Semmelweis Egyetem
Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, Poland
Narodny ustav detskych chorob
Bratislava, Slovakia
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain