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

臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113

32 trials found

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-004348-27-DK (EUCTR)	04/03/2022	22/11/2021	A clinical trial to assess the safety and efficacy of seladelparin patientswith primary biliary chol ...	RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ...	Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and poten ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy; ...
2	NCT04950764 (ClinicalTrials.gov)	September 17, 2021	14/6/2021	An Open-Label Study Following Oral Dosing of Seladelparto Subjects With Primary Biliary Cholangitis ...	The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Followin ...	Primary Biliary Cholangitis;Compensated Cirrhosis;Hepatic Impairment	Drug: Seladelpar 10 mg;Drug: Seladelpar 10 mg or less	CymaBay Therapeutics, Inc.	NULL	Recruiting	18 Years	80 Years	All	24	Phase 1	United States
3	EUCTR2020-004348-27-DE (EUCTR)	07/07/2021	07/01/2021	A clinical trial to assess the safety and efficacy of seladelparin patientswith primary biliary chol ...	RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ...	Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and poten ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Ne ...
4	EUCTR2020-005198-29-NL (EUCTR)	28/06/2021	31/03/2021	A study to evaluate the safety and tolerability of seladelparin subjectswith primary biliary cholang ...	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelparin Subjec ...	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3;Phase 4	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
5	EUCTR2020-004348-27-NL (EUCTR)	08/06/2021	16/03/2021	A clinical trial to assess the safety and efficacy of seladelparin patientswith primary biliary chol ...	RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ...	Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and poten ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 3	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
6	EUCTR2020-005198-29-IT (EUCTR)	04/06/2021	08/06/2021	A study to evaluate the safety and tolerability of seladelparin subjects with primary biliary cholan ...	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelparin Subjec ...	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ...	Product Name: SELADELPAR Product Code: [MBX-8025] INN or Proposed INN: seladelpar Product Name: seladel ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3;Phase 4	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
7	EUCTR2020-005198-29-DE (EUCTR)	10/05/2021	05/02/2021	A study to evaluate the safety and tolerability of seladelparin subjectswith primary biliary cholang ...	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelparin Subjec ...	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3;Phase 4	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
8	EUCTR2020-005198-29-HU (EUCTR)	06/05/2021	21/03/2021	A study to evaluate the safety and tolerability of seladelparin subjectswith primary biliary cholang ...	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelparin Subjec ...	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3;Phase 4	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
9	EUCTR2020-005198-29-PL (EUCTR)	05/05/2021	17/03/2021	A study to evaluate the safety and tolerability of seladelparin subjectswith primary biliary cholang ...	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelparin Subjec ...	Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ...	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ...	CymaBay Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ...
10	NCT04620733 (ClinicalTrials.gov)	April 21, 2021	4/11/2020	RESPONSE: Response to Seladelparin Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate ...	RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ...	Primary Biliary Cholangitis	Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg	CymaBay Therapeutics, Inc.	NULL	Recruiting	18 Years	75 Years	All	180	Phase 3	United States;Argentina;Australia;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Ko ...

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