Trials / Approved For Marketing
Approved For MarketingNCT04530994
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Mirum Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- —
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | maralixibat | Maralixibat is an Apical Sodium-dependent Bile acid Transporter (ASBT) inhibitor |
Timeline
- First posted
- 2020-08-28
- Last updated
- 2021-10-20
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04530994. Inclusion in this directory is not an endorsement.