New drug could soothe unbearable itch in rare liver conditions
NCT ID NCT06553768
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether maralixibat, an oral solution, can safely reduce severe itching (pruritus) in children and adults with rare cholestatic liver diseases. The study enrolls 90 participants aged 6 months and older who have not responded to other treatments. Over 20 weeks, researchers will measure changes in itch severity using a caregiver-reported scale and bile acid levels.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
maralixibat (oral solution)
What this could lead to
If it works, this could provide a new treatment option for severe itching in rare cholestatic liver diseases where other therapies have failed.
What could go wrong
This is a relatively small Phase 3 trial (90 participants) and the primary outcome is a subjective itch score. The drug may not prove effective or could have side effects not yet seen in earlier studies.
Disclaimer
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Children's Hospital Los Angeles (CHLA)
Los Angeles, California, 90027, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Hospital Sírio-Libanês
São Paulo, Brazil
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, Spain
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Hospital da Criança Santo Antonio
Porto Alegre, Brazil
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Hospital de Criança de Brasília (HCB)
Brasília, Brazil
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Hotel Dieu de France
Beirut, Lebanon
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Hôpital Kremlin Bicêtre
Paris, France
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Hôpitaux Universitaires de Marseille Timone
Marseille, 13005, France
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ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, 90127, Italy
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Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
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King's College Hospital NHS Foundation Trust
London, United Kingdom
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Lurie Children's Hospital
Chicago, Illinois, 60611, United States
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Morgan Stanley Children's Hospital - NewYork Presbyterian
New York, New York, 10032, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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NYU Langone Health
New York, New York, 10016, United States
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Ospedale Pediatrico Bambino Gesu
Rome, 00165, Italy
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Stanford Children's Health in Palo Alto
Palo Alto, California, 94304, United States
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Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
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University of Utah
Salt Lake City, Utah, 84112, United States
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Universitätsklinikum Hamburg Eppendorf - Klinik für Kinder- und Jugendmedizin
Hamburg, Germany