93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details


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

  
13 trials found
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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
8EUCTR2016-004599-23-IT
(EUCTR)
26/02/201807/01/2021A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
GENKYOTEX SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy
9EUCTR2016-004599-23-GR
(EUCTR)
27/10/201706/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom
10EUCTR2016-004599-23-DE
(EUCTR)
19/09/201710/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
11EUCTR2016-004599-23-BE
(EUCTR)
10/08/201710/04/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom
12EUCTR2016-004599-23-ES
(EUCTR)
26/07/201704/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
13EUCTR2016-004599-23-GB
(EUCTR)
30/06/201717/05/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom