Hope for rare liver disease: drug aims to ease severe itching in children

NCT ID NCT04185363

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the long-term safety of maralixibat, an oral medication, in children with progressive familial intrahepatic cholestasis (PFIC), a rare liver disease that causes intense itching. Participants who completed a prior study will receive maralixibat twice daily. Researchers will monitor side effects and track changes in itching severity over time.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

maralixibat

What this could lead to

If successful, this could confirm maralixibat as a safe long-term treatment to control itching and improve quality of life in children with PFIC.

What could go wrong

This is an extension study, so results depend on earlier findings. The drug may not work for everyone, and long-term side effects are still being evaluated.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

bile duct disorder biliary tract disorder cholestasis Cholestasis, progressive familial intrahepatic 1 Digestive System Diseases liver disorder progressive familial intrahepatic cholestasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 32803, United States

  • Azienda Ospedaliera Papa Giovanni XXIII - Unita di Pediatria

    Bergamo, 24127, Italy

  • Birmingham Children's Hospital

    Birmingham, United Kingdom

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, 31059, France

  • Children Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital at Montefiore

    The Bronx, New York, 10461, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Consultario de Joshue David Covarrubias Esquer

    Zapopan, Mexico

  • Fundacion Cardioinfantil

    Bogotá, Colombia

  • Groupement Hospitalier Est Hopital, Femme Mère Enfant de Lyon

    Lyon, France

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Argentina

  • Hotel Dieu de France, Alfred Naccache

    Beirut, Lebanon

  • Instytut Pomnik Centrum, Zdrowia Dziecka

    Warsaw, Poland

  • KK Women's and Children's Hospital

    Singapore, Singapore

  • King's College Hospital NHS Foundation Trust

    London, United Kingdom

  • Koc University Hospital

    Istanbul, 34010, Turkey (Türkiye)

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule

    Hanover, Germany

  • Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde

    Vienna, Austria

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Ospedale Pediatrico bambino Gesu'

    Roma, Italy

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

    São Paulo, Brazil

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

    Edmonton, Alberta, Canada

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Texas, Health Science Center San Antonio

    San Antonio, Texas, 78229, United States