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COMPLETED
NCT04185363
PHASE3

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Sponsor: Mirum Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

Official title: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2020-01-08

Completion Date

2025-04-23

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

Maralixibat

All subjects will receive Maralixibat oral solution (up to 600 microgram per kilogram \[mcg/kg\]) twice daily

Locations (28)

Children's Hospital Los Angeles

Los Angeles, California, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Advent Health

Orlando, Florida, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Children Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas, Health Science Center San Antonio

San Antonio, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, Brazil

University of Alberta - Women and Children's Health Research Institute

Edmonton, Alberta, Canada

Fundacion Cardioinfantil

Bogotá, Colombia

Groupement Hospitalier Est Hopital, Femme Mère Enfant de Lyon

Lyon, France

CHU de Toulouse - Hôpital des Enfants

Toulouse, France

Medizinische Hochschule

Hanover, Germany

Azienda Ospedaliera Papa Giovanni XXIII - Unita di Pediatria

Bergamo, Italy

Ospedale Pediatrico bambino Gesu'

Roma, Italy

Hotel Dieu de France, Alfred Naccache

Beirut, Lebanon

Consultario de Joshue David Covarrubias Esquer

Zapopan, Mexico

Instytut Pomnik Centrum, Zdrowia Dziecka

Warsaw, Poland

KK Women's and Children's Hospital

Singapore, Singapore

Koc University Hospital

Istanbul, Turkey (Türkiye)

Birmingham Children's Hospital

Birmingham, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom