METHODS FOR TREATING CHOLESTASIS
Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
1 - 102 . (canceled)
103 . A method for treating progressive familial intrahepatic cholestasis (PFIC) in a subject in need of such treatment comprising administering to the subject maralixibat in an amount of from about 560 μg/kg/day to about 1400 μg/kg/day.
104 . The method of claim 103 , wherein maralixibat is administered in an amount of about 560 μg/kg/day.
105 . The method of claim 103 , wherein maralixibat is administered in an amount of about 1100 μg/kg/day.
106 . The method of claim 103 , wherein maralixibat is administered in an amount of about 1200 μg/kg/day.
107 . The method of claim 103 , wherein maralixibat is administered in an amount from about 10 mg/day to about 100 mg/day.
108 . The method of claim 107 , wherein maralixibat is administered in an amount from about 20 mg/day to about 80 mg/day.
109 . The method of claim 103 , wherein the PFIC is selected from PFIC type 1, PFIC type 2, and PFIC type 3.
110 . The method of claim 109 , wherein the PFIC is PFIC type 1.
111 . The method of claim 109 , wherein the PFIC is PFIC type 2.
112 . The method of claim 109 , wherein the PFIC is PFIC type 3.
113 . The method of claim 103 , wherein maralixibat is administered once daily (QD).
114 . The method of claim 103 , wherein maralixibat is administered twice daily (BID).
115 . The method of claim 103 , wherein maralixibat is administered for at least 18 weeks.
116 . The method of claim 103 , wherein maralixibat is administered for at least 2 years.
117 . The method of claim 103 , wherein maralixibat is administered for at least 3 years.
118 . The method of claim 103 , wherein the subject exhibits below normal height or weight prior to the administration of maralixibat.
119 . The method of claim 103 , wherein the subject experiences pruritus prior to the administration of maralixibat.
120 . The method of claim 103 , wherein the subject is a pediatric subject.
121 . The method of claim 103 , wherein the subject is at least 1 year of age.
122 . The method of claim 103 , wherein maralixibat is administered prior to ingestion of food.
123 . The method of claim 103 , wherein maralixibat is administered orally.