Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis (INDIGO)
Open Label Study of the Efficacy and Long Term Safety of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Patients With Progressive Familial Intrahepatic Cholestasis
Sponsor: Mirum Pharmaceuticals, Inc.
This PHASE2 trial investigates Progressive Familial Intrahepatic Cholestasis (PFIC) and is currently completed. Mirum Pharmaceuticals, Inc. leads this study, which shows 16 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
16 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Nov 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2021 — Nov 2023 [monthly]
Completed PHASE2
-
Sep 2021 — Dec 2021 [monthly]
Completed PHASE2
▶ Show 11 earlier versions
-
Jan 2021 — Sep 2021 [monthly]
Completed PHASE2
-
Jul 2020 — Jan 2021 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
-
Jun 2020 — Jul 2020 [monthly]
Active Not Recruiting PHASE2
-
Dec 2019 — Jun 2020 [monthly]
Active Not Recruiting PHASE2
-
Apr 2019 — Dec 2019 [monthly]
Active Not Recruiting PHASE2
-
Sep 2018 — Apr 2019 [monthly]
Active Not Recruiting PHASE2
-
Jun 2018 — Sep 2018 [monthly]
Active Not Recruiting PHASE2
-
Oct 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE2
-
May 2017 — Oct 2017 [monthly]
Active Not Recruiting PHASE2
-
Feb 2017 — May 2017 [monthly]
Active Not Recruiting PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE2
First recorded
Mar 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Mirum Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .