UDCA ( DrugBank: UDCA )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ1
67多発性嚢胞腎1
93原発性胆汁性胆管炎83
94原発性硬化性胆管炎6
97潰瘍性大腸炎2
296胆道閉鎖症1

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04834557
(ClinicalTrials.gov)
November 1, 20212/4/2021Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid ArthritisEvaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in EgyptRheumatoid ArthritisDrug: Placebo;Drug: Digoxin 0.25 mg;Drug: Ursodeoxycholic acid (UDCA) 500 mgTanta UniversityNULLRecruiting18 Years80 YearsAll90Phase 2Egypt

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000012865
2014/06/3001/03/2014Ursodeoxycholic acid for polycystic liver diseaseUrsodeoxycholic acid for polycystic liver disease - UDCA for PLD polycystic liver disease, polycystic kidney diseaseUDCA 600mg/day
standard treatment
Nephrology Center, Toranomon HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female100Not selectedJapan

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05749822
(ClinicalTrials.gov)
February 17, 202329/12/2022Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary CholangitisFenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CholangitisDrug: Fenofibrate 200mg;Drug: Placebo;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years75 YearsAll104Phase 2/Phase 3China
2NCT05293938
(ClinicalTrials.gov)
March 28, 20224/3/2022A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC PatientsStudy Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary CholangitisPrimary Biliary CholangitisDrug: Obeticholic Acid 5 MG;Drug: Obeticholic Acid 10 MG;Drug: Standard of Care: UDCAIntercept PharmaceuticalsGlobal PBC Study Group;Target RWE;Syneos Health;UK PBC Study GroupEnrolling by invitation18 YearsN/AAll2350United States
3EUCTR2020-004348-27-DK
(EUCTR)
04/03/202222/11/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand;United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary
4NCT05104853
(ClinicalTrials.gov)
January 25, 202222/10/2021Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary CholangitisA Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCAPrimary Biliary CholangitisDrug: CNP-104;Drug: PlaceboCOUR Pharmaceutical Development Company, Inc.NULLRecruiting18 Years75 YearsAll40Phase 1/Phase 2United States
5NCT04956328
(ClinicalTrials.gov)
July 22, 20211/7/2021Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA .Primary Biliary CirrhosisDrug: Obeticholic Acid Tablets;Drug: UDCA;Drug: PlaceboChia Tai Tianqing Pharmaceutical Group Co., Ltd.NULLRecruiting18 Years75 YearsAll120Phase 3China
6EUCTR2020-004348-27-RO
(EUCTR)
08/07/202119/04/2022A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Denmark;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
7EUCTR2020-004348-27-DE
(EUCTR)
07/07/202107/01/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;New Zealand
8EUCTR2020-004348-27-NL
(EUCTR)
08/06/202116/03/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand
9ChiCTR2100046346
2021-06-012021-05-14A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis primary biliary cholangitisUrsodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin;Xiangya Hospital of Central South UniversityNULLRecruiting1875BothUrsodeoxycholic acid group:30;Rifaximin group :30;N/AChina
10NCT04620733
(ClinicalTrials.gov)
April 21, 20214/11/2020RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mgCymaBay Therapeutics, Inc.NULLActive, not recruiting18 Years75 YearsAll193Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;New Zealand;Poland;Romania;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Netherlands
11EUCTR2020-004348-27-PL
(EUCTR)
16/03/202102/02/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand
12EUCTR2020-004348-27-HU
(EUCTR)
04/03/202120/01/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
13EUCTR2020-004348-27-IT
(EUCTR)
16/02/202124/05/2021A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Seladelpar
Product Code: [MBX-8025]
INN or Proposed INN: seladelpar
Product Name: Seladelpar
Product Code: [MBX-8025]
INN or Proposed INN: seladelpar
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
14ChiCTR2000037244
2020-10-012020-08-27A multicenter, randomized, double-blind, Tiaomian I study of PBCA multicenter, randomized, double-blind, Tiaomian I study of PBC Primary biliary cholangitiscontrol group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I;Longhua Hospital ShangHai University of Traditional Chinese MedicineNULLRecruitingBothcontrol group:45;experimental group:45;China
15ITMCTR2000004009
2020-10-012020-08-27A multicenter, randomized, double-blind, Tiaomian I study of PBCA multicenter, randomized, double-blind, Tiaomian I study of PBC Primary biliary cholangitiscontrol group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I;Longhua Hospital ShangHai University of Traditional Chinese MedicineNULLRecruitingBothcontrol group:45;experimental group:45;China
16NCT03954327
(ClinicalTrials.gov)
June 29, 20207/5/2019Combination Antiretroviral Therapy (cART) for PBCRandomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF);Drug: Raltegravir;Drug: Placebo Oral Capsule [CEBOCAP]University of AlbertaMerck Sharp & Dohme Corp.Recruiting18 YearsN/AAll60Phase 2Canada
17NCT03521297
(ClinicalTrials.gov)
January 20, 202028/4/2018Probiotics in PBC Patients of Poor Response to UDCASafety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) ResponsePrimary Biliary Cholangitis (PBC)Drug: Probiotic;Dietary Supplement: PlaceboSun Yat-sen UniversityNULLNot yet recruiting18 Years70 YearsAll60Phase 2China
18ITMCTR1900025303
2019-11-302019-10-29A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosisA multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis primary biliary cirrhosisExperimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA;Longhua Hospital, Shanghai University of Traditional Chinese MedicineNULLRecruiting1865BothExperimental group:136;Control group:136;China
19ITMCTR1900002705
2019-11-302019-10-23Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western MedicineStudy for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine primary biliary cholangitisTreatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA;Longhua Hospital, Shanghai University of traditional Chinese MedicineNULLPending1865BothTreatment group :120;Control group:120;China
20ChiCTR1900027043
2019-11-302019-10-29A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosisA multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis primary biliary cirrhosisExperimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA;Longhua Hospital, Shanghai University of Traditional Chinese MedicineNULLRecruiting1865BothExperimental group:136;Control group:136;China
21ChiCTR1900026813
2019-11-302019-10-23Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western MedicineStudy for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine primary biliary cholangitisTreatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA;Longhua Hospital, Shanghai University of traditional Chinese MedicineNULLPending1865BothTreatment group :120;Control group:120;China
22NCT04076527
(ClinicalTrials.gov)
September 19, 201929/8/2019Prospective, Multicenter Cohort Study on Primary Biliary CholangitisProspective, Multicenter Cohort Study on Primary Biliary CholangitisPBC;Primary Biliary CholangitisDrug: UDCA;Drug: OcalivaUniversity of LeipzigRWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical SchoolRecruiting18 YearsN/AAll1200Germany
23EUCTR2018-003365-34-GB
(EUCTR)
02/05/201911/02/2019A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAA Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA Primary Biliary Cholangitis
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Italy;United Kingdom
24EUCTR2018-001171-20-AT
(EUCTR)
29/04/201919/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
25EUCTR2018-003365-34-IT
(EUCTR)
18/04/201903/08/2021A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA.A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na Primary Biliary Cholangitis
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
Other descriptive name: baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLNot RecruitingFemale: yes
Male: yes
52Phase 2United States;United Kingdom;Italy
26EUCTR2018-001171-20-NL
(EUCTR)
18/04/201916/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
27NCT03742973
(ClinicalTrials.gov)
March 28, 201914/11/2018A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAA Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCAPrimary Biliary CholangitisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLTerminated18 YearsN/AAll2Phase 2United States;Puerto Rico;Italy;United Kingdom
28EUCTR2018-001171-20-BE
(EUCTR)
06/03/201929/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
29EUCTR2018-001171-20-FR
(EUCTR)
23/01/201918/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
30EUCTR2017-003528-62-BE
(EUCTR)
11/01/201924/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain
31EUCTR2018-001171-20-PL
(EUCTR)
27/12/201806/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
32EUCTR2018-001171-20-ES
(EUCTR)
21/12/201818/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
33EUCTR2018-001171-20-DE
(EUCTR)
20/12/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
34ChiCTR1800020160
2018-12-202018-12-18Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosisClinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis Primary Biliary Cirrhosis1:Fenofibrate+UDCA;2:UDCA;Peking Union Medical College HosipitalNULLRecruiting1865Both1:20;2:20;China
35EUCTR2017-003528-62-DE
(EUCTR)
05/12/201816/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
36EUCTR2017-003528-62-NL
(EUCTR)
29/11/201809/07/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom
37EUCTR2018-001171-20-HU
(EUCTR)
26/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
38EUCTR2018-001171-20-GR
(EUCTR)
23/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
39EUCTR2018-001171-20-IT
(EUCTR)
08/11/201817/06/2021A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate thesafety and efficacy of seladelpar in subjects with primary biliary cholangitis(PBC) and an inadequate response to or intolerance to ursodeoxycholicacid (UDCA). - NA Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) andaccumulation of toxic bile acids (BA).
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: seladelpar
Product Code: [MXB-8025]
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: [MBX-8025]
INN or Proposed INN: seladelpar
CymaBay Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of;Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil
40EUCTR2017-003528-62-AT
(EUCTR)
19/10/201825/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain
41NCT03602560
(ClinicalTrials.gov)
October 1, 201818/7/2018ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: PlaceboCymaBay Therapeutics, Inc.NULLCompleted18 Years75 YearsAll265Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom
42EUCTR2017-003528-62-ES
(EUCTR)
28/08/201824/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
43EUCTR2017-003528-62-GB
(EUCTR)
27/07/201822/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
44NCT03476993
(ClinicalTrials.gov)
April 27, 201820/3/2018Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary CholangitisOpen-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary CholangitisLiver Cirrhosis, BiliaryBiological: BCD-085BiocadNULLTerminated18 Years60 YearsAll9Phase 2Russian Federation
45NCT03394924
(ClinicalTrials.gov)
December 27, 201723/12/2017A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary CholangitisA Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: PlaceboEnanta PharmaceuticalsPharmaceutical Research Associates;Triangle BiostatisticsCompleted18 Years75 YearsAll68Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom
46EUCTR2016-002996-91-DE
(EUCTR)
21/02/201717/11/2016A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
47EUCTR2016-002996-91-GB
(EUCTR)
12/01/201721/11/2016A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: Seladelpar
Other descriptive name: MBX-8025
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
48NCT02823353
(ClinicalTrials.gov)
April 8, 201628/1/2016Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisFenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control StudyPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCAXijing Hospital of Digestive DiseasesNULLCompleted18 Years70 YearsAll117Phase 3China
49EUCTR2015-002698-39-PL
(EUCTR)
03/03/201608/01/2016A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
50NCT02823366
(ClinicalTrials.gov)
January 201628/1/2016Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsAll104Phase 3China
51NCT02965911
(ClinicalTrials.gov)
January 201615/11/2016Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCAA Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCAPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCABeijing 302 HospitalNULLWithdrawn18 Years65 YearsAll0Phase 1/Phase 2China
52NCT02916290
(ClinicalTrials.gov)
January 201628/1/2016Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
53NCT02916641
(ClinicalTrials.gov)
January 201628/1/2016Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
54EUCTR2015-002698-39-DE
(EUCTR)
18/12/201530/09/2015A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 19.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
INN or Proposed INN: NA
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
INN or Proposed INN: NA
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
55EUCTR2015-002698-39-GB
(EUCTR)
11/11/201517/09/2015A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
56NCT02609048
(ClinicalTrials.gov)
November 201513/11/2015Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary Cirrhosis (PBC)Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mgCymaBay Therapeutics, Inc.NULLTerminated18 Years75 YearsAll41Phase 2United States;Canada;Germany;Poland;United Kingdom
57NCT02026401
(ClinicalTrials.gov)
February 201430/12/2013Phase 2 Study of NGM282 in Patients With Primary Biliary CirrhosisA Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisBiological: NGM282;Biological: PlaceboNGM Biopharmaceuticals, IncNGM Biopharmaceuticals Australia Pty LtdCompleted18 Years75 YearsAll45Phase 2United States;Australia
58NCT01904058
(ClinicalTrials.gov)
August 201317/7/2013Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary CirrhosisA Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary CirrhosisPBC;Primary Biliary CirrhosisDrug: LUM001;Drug: Placebo;Drug: Ursodeoxycholic AcidMirum Pharmaceuticals, Inc.NULLCompleted18 Years80 YearsAll66Phase 2United States;Canada;United Kingdom
59EUCTR2013-000482-36-GB
(EUCTR)
08/07/201313/05/2013Phase 2 study to investigate use of LUM001 as a treatment for Primary Biliary Cirrhosis (PBC). This is a chronic and slowly progressive cholestatic liver disease of autoimmune aetiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure.A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifthto seventh decades of life at time of diagnosis, and 90% are women.
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: LUM001
INN or Proposed INN: LUM001
Lumena Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;United Kingdom
60EUCTR2007-004040-70-PL
(EUCTR)
30/04/201320/03/2013Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
61EUCTR2011-004681-15-AT
(EUCTR)
09/11/201119/10/2011Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosisEffects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezafibrat Genericon retard 400 mg
Product Name: Bezafibrat
Product Code: 1-20190
INN or Proposed INN: BEZAFIBRATE
Product Name: Ursodeoxycholsäure
Other descriptive name: URSODEOXYCHOLIC ACID
Medizinische Universität GrazNULLNot RecruitingFemale: yes
Male: yes
Austria
62EUCTR2011-000554-31-SE
(EUCTR)
26/10/201116/08/2011A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI Primary Biliary Cirrhosis
MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2France;United States;Canada;Germany;Italy;United Kingdom;Sweden
63EUCTR2011-000554-31-GB
(EUCTR)
21/09/201112/07/2011A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI Primary Biliary Cirrhosis
MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2France;United States;Canada;Germany;Italy;United Kingdom;Sweden
64NCT01389973
(ClinicalTrials.gov)
September 20117/7/2011A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary CirrhosisDrug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll20Phase 2United States;Canada
65EUCTR2011-001326-26-IT
(EUCTR)
21/06/201119/01/2012Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody.Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of increased ALP levels for at least 6 months - Positive serum AMA titer (>1:40) - Liver biopsy consistent with PBC Patient should be on incomplete response to UDCA
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0801
Product Code: NI-0801
NOVIMMUNE BVNULLNot RecruitingFemale: yes
Male: yes
40Italy
66NCT01141296
(ClinicalTrials.gov)
April 20118/6/2010Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary CirrhosisRandomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: fenofibrate;Drug: placeboUniversity of MiamiMayo ClinicWithdrawn21 Years75 YearsBoth0Phase 2United States
67EUCTR2007-001425-10-AT
(EUCTR)
13/03/200927/08/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
68EUCTR2007-001425-10-NL
(EUCTR)
11/02/200903/09/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
69EUCTR2007-004040-70-DK
(EUCTR)
29/01/200919/11/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
70EUCTR2007-001425-10-DE
(EUCTR)
27/01/200924/10/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140United Kingdom;Germany;Netherlands;France;Spain;Austria
71EUCTR2007-004040-70-LT
(EUCTR)
22/12/200816/09/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
72EUCTR2007-004040-70-FI
(EUCTR)
10/11/200825/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
73NCT01510860
(ClinicalTrials.gov)
November 200812/1/2012Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary CirrhosisDouble-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: UDCA (Ursodeoxycholic acid)Dr. Falk Pharma GmbHNULLCompleted18 YearsN/AAll65Phase 4Germany
74EUCTR2007-004040-70-HU
(EUCTR)
18/10/200804/08/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
75EUCTR2007-001425-10-GB
(EUCTR)
13/10/200827/06/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
76EUCTR2007-001425-10-FR
(EUCTR)
26/09/200806/08/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Spain;Austria;Germany;Netherlands;United Kingdom
77EUCTR2007-001425-10-ES
(EUCTR)
24/09/200823/07/2008Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisEstudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis cirrosis biliar primaria
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Spain;Austria;Germany;Netherlands;United Kingdom
78EUCTR2007-004040-70-SE
(EUCTR)
22/09/200802/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
79EUCTR2007-004040-70-NL
(EUCTR)
11/08/200823/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
80EUCTR2007-004040-70-DE
(EUCTR)
15/05/200814/03/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
81NCT00550862
(ClinicalTrials.gov)
October 200727/10/2007Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)A Study of INT 747 (6a-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: INT-747;Drug: Ursodeoxycholic Acid (URSO);Drug: PlaceboIntercept PharmaceuticalsNULLCompleted18 Years70 YearsAll165Phase 2United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom
82EUCTR2006-003712-22-DE
(EUCTR)
23/10/200618/09/2006Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteersPharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers Primary Biliary Cirrhosis Stage I-III
MedDRA version: 12.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® 500 mg Filmtabletten
Product Name: Ursofalk® 500 mg Filmtabletten
INN or Proposed INN: Ursodeoxycholic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
24Germany
83JPRN-C000000225
2003/12/0113/09/2008Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosisRandomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis - GLSG,2004,PBC Primary biliary cirrhosisIntervention:UDCA+Bezafibrate
Bezafibrate: 400mg/day for 12 months
Dose of pretreatment UDCA is not changed after entry.
control:UDCA only
Dose of pretreatment UDCA is not changed after entry.
Gunma Liver Study GroupNULLComplete: follow-up complete20years-old85years-oldMale and Female20Not applicableJapan

94. 原発性硬化性胆管炎


臨床試験数 : 148 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04309773
(ClinicalTrials.gov)
April 6, 202118/10/2019Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid TherapyDouble Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid TherapyPrimary Sclerosing Cholangitis;CholestasisDrug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Bezafibrate in addition to standard UDCA therapyAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years75 YearsAll104Phase 3France
2NCT03678480
(ClinicalTrials.gov)
March 1, 202118/9/2018A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;AdolescentDrug: HTD1801;Drug: Ursodeoxycholic AcidHighTide Biopharma Pty LtdNULLWithdrawn12 Years17 YearsAll0Phase 2NULL
3NCT03516006
(ClinicalTrials.gov)
January 201720/9/2017Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing CholangitisIntra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: UCMSC;Drug: UDCAFuzhou General HospitalNULLActive, not recruiting18 Years65 YearsAll20Phase 1/Phase 2NULL
4EUCTR2015-003310-24-SE
(EUCTR)
09/10/201501/09/2015Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) - UDCAPSCSURV Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Ursofalk
Product Name: Ursofalk
Sahlgrenska AcademyNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Sweden
5NCT01456468
(ClinicalTrials.gov)
October 201114/10/2011Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing CholangitisCombination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot StudyCholangitis, SclerosingDrug: Oral all-trans retinoic acid (ATRA)Yale UniversityMayo ClinicCompleted18 Years80 YearsBoth19Phase 1United States
6NCT01088607
(ClinicalTrials.gov)
October 201012/3/2010Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing CholangitisUrsodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution TrialPrimary Sclerosing CholangitisDrug: ursodeoxycholic acid (UDCA)University of TennesseeIcahn School of Medicine at Mount Sinai;Ann & Robert H Lurie Children's Hospital of Chicago;University of Colorado, Denver;University of California, San Francisco;University of Pittsburgh;Phoenix Children's Hospital;Children's Hospital of Philadelphia;Children's Healthcare of Atlanta;Children's Hospital Los Angeles;Texas Children's Hospital;Yale UniversityCompleted5 Years21 YearsAll27Phase 1United States;Canada

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03724175
(ClinicalTrials.gov)
August 26, 201912/10/2018The Role of Secondary Bile Acids in Intestinal InflammationThe Role of Secondary Bile Acids in Intestinal InflammationUlcerative Colitis;PouchitisDrug: ursodiol (ursodeoxycholic acid, UDCA)Stanford UniversityNULLRecruiting18 Years70 YearsAll15Phase 2/Phase 3United States
2EUCTR2009-010921-38-NL
(EUCTR)
08/09/200902/03/2009Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UCChemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC Ulcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Trade Name: Ursofalk
INN or Proposed INN: ursodeoxycholic acid
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands

296. 胆道閉鎖症


臨床試験数 : 71 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1800015250
2018-01-012018-03-19The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trialThe Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial biliary atresiahigh-dose:UDCA 25mg/kg po;low-dose:UDCA 15mg/kg po;Children's Hospital of Fudan UniversityNULLRecruitingBothhigh-dose:100;low-dose:100;China