93. Primary biliary cholangitis
230 clinical trials,   215 drugs   (DrugBank: 51 drugs),   34 drug target genes,   107 drug target pathways

Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
66 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04620733
(ClinicalTrials.gov)
January 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.NULLNot yet recruiting18 Years75 YearsAll180Phase 3NULL
2NCT03954327
(ClinicalTrials.gov)
September 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.Not yet recruiting18 YearsN/AAll60Phase 2Canada
3NCT03521297
(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
4ChiCTR1900027043
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
5ChiCTR1900026813
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04076527
(ClinicalTrials.gov)
September 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 SchoolNot yet recruiting18 YearsN/AAll1200Germany
7EUCTR2018-003365-34-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]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
52Phase 2United States;Italy;United Kingdom
8EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
9EUCTR2018-001171-20-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 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
10NCT03742973
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
12EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
13EUCTR2017-003528-62-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 2France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
14EUCTR2018-001171-20-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
15EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
17EUCTR2017-003528-62-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
18EUCTR2017-003528-62-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
19NCT03602560
(ClinicalTrials.gov)
November 26, 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.NULLSuspended18 Years75 YearsAll240Phase 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
20EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-001171-20-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]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;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
22EUCTR2017-003528-62-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]
Enanta Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Australia;Austria;Netherlands;Germany;United Kingdom
23EUCTR2017-003528-62-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
24EUCTR2017-003528-62-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
25NCT03476993
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03394924
(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
27EUCTR2016-002996-91-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]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128Phase 2United States;Canada;Germany;United Kingdom
28EUCTR2016-002996-91-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]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128Phase 2United States;Canada;Germany;United Kingdom
29NCT02955602
(ClinicalTrials.gov)
November 28, 20162/11/2016Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)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 CirrhosisDrug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg CapsuleCymaBay Therapeutics, Inc.NULLCompleted18 Years75 YearsAll119Phase 2United States;Canada;Germany;United Kingdom
30NCT02931513
(ClinicalTrials.gov)
September 201611/10/2016sCD163 in PBC Patients - Assessment of Treatment ResponseMacrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCAPrimary Biliary Cirrhosis;Liver Inflammation;Ursodeoxycholic AcidOther: Blood samples;Device: Fibroscan;Other: Questionnaires;Biological: Liver biopsyUniversity of AarhusNULLRecruiting18 YearsN/AAll40Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2015-002698-39-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
32NCT02823353
(ClinicalTrials.gov)
January 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 DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
33NCT02965911
(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 HospitalNULLRecruiting18 Years65 YearsBoth72Phase 1;Phase 2China
34NCT02916290
(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
35NCT02823366
(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 YearsBoth200Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02916641
(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
37EUCTR2015-002698-39-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
38EUCTR2015-002698-39-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
39NCT02609048
(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
40NCT02026401
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01904058
(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
42EUCTR2013-000482-36-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
43EUCTR2007-004040-70-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
44EUCTR2011-004681-15-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
45EUCTR2011-000554-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2011-000554-31-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
47NCT01389973
(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
48EUCTR2011-001326-26-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
49NCT01141296
(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
50EUCTR2007-001425-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2007-001425-10-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
52EUCTR2007-004040-70-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
53EUCTR2007-001425-10-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
54EUCTR2007-004040-70-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
55EUCTR2007-004040-70-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01510860
(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
57EUCTR2007-004040-70-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
58EUCTR2007-001425-10-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
59EUCTR2007-001425-10-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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
60EUCTR2007-001425-10-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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-004040-70-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
62EUCTR2007-004040-70-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
63EUCTR2007-004040-70-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
64NCT00550862
(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
65EUCTR2006-003712-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66JPRN-C000000225
2003/12/0113/09/2008Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis 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