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16 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
volixibat (SAR 548304) / Mirum Pharma
2020-003027-41: A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitis

Not yet recruiting
2
300
Europe
Volixibat (formely SHP626, LUM002 or SAR548304B), Capsule, hard
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Pruritus associated with Primary Sclerosing Cholangitis (PSC), Itching in patients with primary sclerosing cholangitis, Diseases [C] - Digestive System Diseases [C06]
 
 
2021-001389-39: A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary biliary cholangitis

Not yet recruiting
2
260
Europe
volixibat, [volixibat], Capsule, hard
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals Inc., Mirum Pharmaceuticals, Inc.
Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC), Itching in patients with Primary Biliary Cholangitis (PBC), Diseases [C] - Digestive System Diseases [C06]
 
 
OHANA, NCT04718961: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy

Terminated
2
4
Europe, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc.
Intrahepatic Cholestasis of Pregnancy
12/22
12/22
VANTAGE, NCT05050136 / 2021-001389-39: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Recruiting
2
180
Europe, Canada, Japan, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis, PBC
12/25
12/25
VISTAS, NCT04663308 / 2020-003027-41: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Recruiting
2
200
Europe, Canada, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
09/25
12/25
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
NCT04185363 / 2019-003395-39: An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Completed
3
90
Europe, Canada, US, RoW
Maralixibat
Mirum Pharmaceuticals, Inc.
Progressive Familial Intrahepatic Cholestasis (PFIC)
04/25
04/25
NCT06553768: Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

Recruiting
3
90
Europe, Canada, US, RoW
Maralixibat, Formerly LUM001, SHP625, Placebo
Mirum Pharmaceuticals, Inc.
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
10/26
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).

Completed
2
27
Europe, US, RoW
Maralixibat, Formerly LUM001 and SHP625
Mirum Pharmaceuticals, Inc.
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
12/24
12/24
EMBARK, NCT04524390 / 2020-000974-22: Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

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

Completed
2
52
Europe, Canada, US, RoW
Maralixibat, Formerly LUM001 and SHP625
Mirum Pharmaceuticals, Inc.
Cholestatic Liver Disease
09/24
09/24
LEAP, NCT06193928: Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (-US)

Recruiting
N/A
70
US
Livmarli, Maralixibat
Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
09/28
09/30
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
volixibat (SAR 548304) / Mirum Pharma
2020-003027-41: A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitis

Not yet recruiting
2
300
Europe
Volixibat (formely SHP626, LUM002 or SAR548304B), Capsule, hard
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Pruritus associated with Primary Sclerosing Cholangitis (PSC), Itching in patients with primary sclerosing cholangitis, Diseases [C] - Digestive System Diseases [C06]
 
 
2021-001389-39: A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary biliary cholangitis

Not yet recruiting
2
260
Europe
volixibat, [volixibat], Capsule, hard
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals Inc., Mirum Pharmaceuticals, Inc.
Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC), Itching in patients with Primary Biliary Cholangitis (PBC), Diseases [C] - Digestive System Diseases [C06]
 
 
OHANA, NCT04718961: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy

Terminated
2
4
Europe, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc.
Intrahepatic Cholestasis of Pregnancy
12/22
12/22
VANTAGE, NCT05050136 / 2021-001389-39: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Recruiting
2
180
Europe, Canada, Japan, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis, PBC
12/25
12/25
VISTAS, NCT04663308 / 2020-003027-41: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Recruiting
2
200
Europe, Canada, US, RoW
Volixibat, SHP626, Placebo
Mirum Pharmaceuticals, Inc., Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
09/25
12/25
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
NCT04185363 / 2019-003395-39: An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Completed
3
90
Europe, Canada, US, RoW
Maralixibat
Mirum Pharmaceuticals, Inc.
Progressive Familial Intrahepatic Cholestasis (PFIC)
04/25
04/25
NCT06553768: Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

Recruiting
3
90
Europe, Canada, US, RoW
Maralixibat, Formerly LUM001, SHP625, Placebo
Mirum Pharmaceuticals, Inc.
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
10/26
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).

Completed
2
27
Europe, US, RoW
Maralixibat, Formerly LUM001 and SHP625
Mirum Pharmaceuticals, Inc.
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
12/24
12/24
EMBARK, NCT04524390 / 2020-000974-22: Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

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

Completed
2
52
Europe, Canada, US, RoW
Maralixibat, Formerly LUM001 and SHP625
Mirum Pharmaceuticals, Inc.
Cholestatic Liver Disease
09/24
09/24
LEAP, NCT06193928: Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (-US)

Recruiting
N/A
70
US
Livmarli, Maralixibat
Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
09/28
09/30

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