GYPP-06 (GKT137831 free base), C10071301-D ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎7

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2021-001810-13-SE
(EUCTR)
06/04/202230/11/2021A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
2EUCTR2021-001810-13-DE
(EUCTR)
10/02/202207/10/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
3EUCTR2021-001810-13-ES
(EUCTR)
17/01/202219/10/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
4EUCTR2021-001810-13-AT
(EUCTR)
13/01/202211/10/2021A Trial of Setanaxib in Patients with Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
5EUCTR2021-001810-13-PL
(EUCTR)
11/01/202228/10/2021A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
6EUCTR2021-001810-13-HU
(EUCTR)
11/12/202130/09/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
7EUCTR2021-001810-13-GR
(EUCTR)
07/12/202112/11/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden