Summary

Eligibility
for people ages 12 months and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started

Description

Summary

An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US. Access can be requested through Clinigen Healthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.

Official Title

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome

Details

The objective of this EAP is to provide access to maralixibat for eligible ALGS patients with cholestatic pruritus. Participants will be treated with 400 µg/kg/day with safety and tolerability evaluated on an ongoing basis.

Keywords

Alagille Syndrome, Liver Disease, ALGS, Maralixibat, Bile Duct Diseases, Digestive System Diseases, Biliary Tract Diseases, Cholestasis, Pruritis, Pruritus, Syndrome

Eligibility

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • Stanford University
    Redwood City California 94063 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Mirum Pharmaceuticals, Inc.
Links
Genetics Home Reference - Alagille syndrome Mirum Pharmaceuticals homepage
ID
NCT04530994
Study Type
Expanded Access
Last Updated