RecruitingPhase 3NCT06321601

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.

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)

Sponsor

Amgen

Enrollment

20 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Vasculitis

Summary

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Avacopan for people with vasculitis. The study is currently recruiting participants at 34 locations. People eligible for this study include aged 6 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAvacopan

Oral administration

Locations(34)

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

British Columbia Childrens Hospital

Vancouver, British Columbia, 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

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06321601

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