NCT04729751 - A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 9, 2021

Primary Completion Date

December 17, 2024

Study Completion Date

December 17, 2024

Conditions

Progressive Familial Intrahepatic CholestasisAlagille SyndromeCholestatic Liver Disease

Interventions

DRUG

Maralixibat

"Maralixibat chloride provided in the form of an oral solution (i.e., 5, 10, 15, and 20 mg/mL)~* 400 μg/kg maralixibat chloride is equivalent to 380 µg/kg maralixibat free base~* 600 μg/kg maralixibat chloride is equivalent to 570 µg/kg maralixibat free base"

Trial Locations (14)

15224

Children's Hospital of Pittsburgh, Pittsburgh

20007

Medstar Georgetown University Hospital, Washington D.C.

45050

Consultorio de Joshue David Covarrubias Esquer, Zapopan

70121

Ochsner Hospital for Children, New Orleans

77030

Texas Children's Hospital, Houston

90027

Children Hospital LA, Los Angeles

94158

University of California - San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

Unknown

Cliniques Universitaires Saint-Luc, Brussels

Hôpital Kremlin Bicêtre, Le Kremlin-Bicêtre

Hopital Necker, Paris

Instytut Pomnik-Centrum Zdrowia Dziecka, Warsaw

King's College Hospital, London

01308-000

Sociedade Beneficente de Senhoras - Hospital Sírio-Libanês, São Paulo