Maralixibat (formely shp625 or lum001)    (DrugBank: Maralixibat)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
296胆道閉鎖症0
297アラジール症候群5

296. 胆道閉鎖症 [臨床試験数:53,薬物数:56(DrugBank:31),標的遺伝子数:43,標的パスウェイ数:50
Searched query = "Biliary atresia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 53 trial found

297. アラジール症候群 [臨床試験数:26,薬物数:16(DrugBank:8),標的遺伝子数:2,標的パスウェイ数:2
Searched query = "Alagille syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 26 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2019-002755-42-FR
(EUCTR)
24/03/202016/01/2020MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic Liver Disease.MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study. Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
53Phase 2United States;France;Canada;Spain;Poland;Belgium;Australia;United Kingdom
2EUCTR2019-002755-42-GB
(EUCTR)
19/03/202023/12/2019MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic Liver Disease.MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study. Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
53Phase 2United States;France;Canada;Spain;Poland;Belgium;Australia;United Kingdom
3EUCTR2019-002755-42-PL
(EUCTR)
08/01/2020MERGE: Maralixibat Extension Safety Study Providing Long-term Treatment to Subjects with Cholestatic Liver Disease.MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study. Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc.NULLNAFemale: yes
Male: yes
53Phase 2France;United States;Canada;Belgium;Spain;Poland;Australia;United Kingdom
4EUCTR2020-004628-40-FR
(EUCTR)
16/12/2020Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome.Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome. - Maralixibat Infant Safety Evaluation (RISE). Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome.
MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals IncNULLNAFemale: yes
Male: yes
12Phase 2France;Poland;Belgium;United Kingdom
5EUCTR2020-004628-40-BE
(EUCTR)
15/12/2020Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome.Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome. - Maralixibat Infant Safety Evaluation (RISE). Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome.
MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat (formely SHP625 or LUM001)
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals IncNULLNAFemale: yes
Male: yes
12Phase 2France;Poland;Belgium;United Kingdom