| Livmarli (maralixibat) / Mirum Pharma |
NCT05543187: A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) |
|
|
| Active, not recruiting | 3 | 5 | Japan | TAK-625, Maralixibat chloride | Takeda | Progressive Familial Intrahepatic Cholestasis (PFIC) | 09/23 | 07/25 | | |
NCT05543174: A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS) |
|
|
| Active, not recruiting | 3 | 7 | Japan | TAK-625, Maralixibat chloride | Takeda | Alagille Syndrome (ALGS) | 10/23 | 07/25 | | |
| Active, not recruiting | 3 | 90 | Europe, Canada, US, RoW | Maralixibat | Mirum Pharmaceuticals, Inc. | Progressive Familial Intrahepatic Cholestasis (PFIC) | 12/24 | 12/24 | | |
NCT06553768: Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) |
|
|
| Recruiting | 3 | 90 | Europe, US, RoW | Maralixibat, Formerly LUM001, SHP625, Placebo | Mirum Pharmaceuticals, Inc. | Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) | 09/26 | 02/27 | | |
NCT06413368: Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study |
|
|
| Not yet recruiting | 2/3 | 20 | US | Maralixibat 9.5 MG/ML [Livmarli] | Children's Hospital Los Angeles | Constipation Chronic Idiopathic, Cystic Fibrosis | 06/26 | 06/27 | | |
NCT02055768: Safety and Efficacy Study of the Intestinal Bile Acid Transport (IBAT) in the Reduction of Pruritus in ALGS |
|
|
| Not yet recruiting | 2 | 24 | US, Canada | LUM001 70 ug/kg/day, Intestinal Bile Acid Transport (IBAT) Inhibitor, Placebo, LUM001 140 ug/kg/day | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Lumena Pharmaceuticals, Inc. | Pruritus, Alagille Syndrome | 02/15 | 05/15 | | |
2015-000906-20: An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Alagille Syndrome (ALGS) or Progressive Familial Intrahepatic Cholestasis (PFIC) |
|
|
| Ongoing | 2 | 120 | Europe | LUM001, LUM001, Oral solution | Shire Human Genetic Therapies Inc, Shire Human Genetic Therapies Inc | Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC), Cholestatic liver diseases associated with either ALGS or PFIC. Long term extension study allowing extended treatment for patients from both the ALGS and PFIC study programmes, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | | | | |
RISE, NCT04729751 / 2020-004628-40: 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). |
|
|
| Active, not recruiting | 2 | 12 | Europe, US, RoW | Maralixibat, Formerly LUM001 and SHP625 | Mirum Pharmaceuticals, Inc. | Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease | 08/23 | 12/24 | | |
| Completed | 2 | 75 | Europe, US, RoW | Maralixibat, Formerly LUM001 and SHP625, Placebo | Mirum Pharmaceuticals, Inc. | Biliary Atresia | 11/23 | 02/24 | | |
MERGE, NCT04168385 / 2019-002755-42: MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study |
|
|
| Active, not recruiting | 2 | 52 | Europe, Canada, US, RoW | Maralixibat, Formerly LUM001 and SHP625 | Mirum Pharmaceuticals, Inc. | Cholestatic Liver Disease | 07/24 | 07/24 | | |
LEAP, NCT06193928: Long-Term Safety and Clinical Outcomes of Livmarli in Patients With Alagille Syndrome |
|
|
| Recruiting | N/A | 50 | US | Maralixibat | Mirum Pharmaceuticals, Inc. | Alagille Syndrome | 09/28 | 09/28 | | |