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 93. 原発性胆汁性胆管炎 [臨床試験数:114,薬物数:136(DrugBank:42),標的遺伝子数:27,標的パスウェイ数:19] 

Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03954327February 202014 October 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 recruiting18 YearsN/AAll60Phase 2Canada
2NCT04076527September 201916 September 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 recruiting18 YearsN/AAll1200N/AGermany
3NCT04047160August 29, 201930 September 2019Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)A Single-Center, Open-Label, Dose-Escalation Study of Cyclic Adenosine Monophosphate (AMP)-Response Element-binding (CREB)-Binding Protein (CBP) / ß-Catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I)Primary Biliary Cholangitis (PBC);Liver Cirrhosis, BiliaryDrug: OP-724Komagome HospitalOHARA Pharmaceutical Co., Ltd.;Japan Agency for Medical Research and DevelopmentRecruiting20 Years74 YearsAll12Phase 1Japan
4NCT03995212June 25, 201911 November 2019Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe PruritusA Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe PruritusCholestatic PruritusDrug: CR845 1.0 mg;Drug: PlaceboCara Therapeutics, Inc.Recruiting18 Years80 YearsAll60Phase 2United States
5NCT03742973March 28, 20194 November 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 UDCAPrimary Biliary CholangitisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll2Phase 2United States;Puerto Rico;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-003528-62-BE11/01/201930 April 2019A 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). - INTREPIDPrimary 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
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: EDP-305
Product Code: EDP-305
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Enanta Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
119Phase 2France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
7ChiCTR18000201602018-12-2014 January 2019Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosisClinical research for fenofibrate in the treatment of refractory primary biliary cirrhosisPrimary Biliary Cirrhosis1:Fenofibrate+UDCA;2:UDCA;Peking Union Medical College HosipitalRecruiting1865Both1:20;2:20;Pilot studyChina
8EUCTR2018-001171-20-DE20/12/201828 February 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
Pharmaceutical Form: Capsule
INN or Proposed INN: SELADELPAR
CAS Number: 928821-40-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule
INN or Proposed INN: SELADELPAR
CAS Number: 928821-40-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
CymaBay Therapeutics, Inc.Authorised 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
9EUCTR2017-003528-62-DE05/12/201830 April 2019A 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). - INTREPIDPrimary 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
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: EDP-305
Product Code: EDP-305
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Enanta Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
10EUCTR2017-003528-62-NL29/11/201828 February 2019A 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). - INTREPIDPrimary 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
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: EDP-305
Product Code: EDP-305
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Enanta Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03602560November 26, 201828 October 2019ENHANCE: 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.Recruiting18 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
12EUCTR2017-001762-13-BE24/10/20187 January 2019A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic ImpairmentPrimary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Intercept Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
13EUCTR2017-003528-62-ES28/08/20183 September 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). - INTREPIDPrimary 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
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: EDP-305
Product Code: EDP-305
Pharmaceutical Form: Tablet
INN or Proposed INN: EDP-305
CAS Number: 1933507-63-1
Current Sponsor code: EDP-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Enanta Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
14EUCTR2017-001762-13-ES01/08/201820 August 2018A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic ImpairmentPrimary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Intercept Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
50Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
15NCT03521297July 20, 201816 July 2018Curative Effect Observation of UDCA Combined Probiotics Therapy in PBC of Poor Response to UDCAThe Comparison of Curative Effects of UDCA Combined Probiotics With Single UDCA Therapy in Primary Biliary Cholangitis of Poor Response to UDCA: A Randomized Controlled TrialPrimary Biliary CholangitisDrug: UDCA combined probioticsSun Yat-sen UniversityNot recruiting30 Years70 YearsAll40Phase 1/Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03476993April 27, 201822 October 2019Non-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-085BiocadNot recruiting18 Years60 YearsAll9Phase 2Russian Federation
17JPRN-UMIN0000313842018/03/162 April 2019Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)PBC patients with osteoporosisDenosumab group
(60 mg Denosumab is administered subcutaneously every 6 month)
Zoledronic acid group
(5 mg Zoledronic acid is administered intravenously every 12 month)
Tokai University School of MedicineMinistry of Health, Labour and WelfareRecruiting20years-old89years-oldMale and Female80Not selectedJapan
18NCT03345589January 30, 201811 June 2018A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary CholangitisA Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary CholangitisPrimary Biliary CholangitisDrug: 18-22mg/kg/d Ursodeoxycholic;Drug: 13-15mg/kg/d UrsodeoxycholicWest China HospitalRecruiting18 Years70 YearsAll40Phase 4China
19NCT03665519January 3, 201817 September 2018Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary CholangitisClinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary CholangitisPrimary Biliary CirrhosisDrug: Ursodeoxycholic Acid;Dietary Supplement: Sublimated mare milkNational Scientific Medical Center, KazakhstanEurasia Invest Ltd., Kazakhstan;Ministry of education and science Republic of KazakhstanRecruiting18 Years75 YearsAll40N/AKazakhstan
20NCT03394924December 27, 201726 August 2019A 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 BiostatisticsRecruiting18 Years75 YearsAll119Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03155932December 15, 201727 May 2019Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary CholangitisAn Open-label, Pilot, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Etrasimod (APD334) in Patients With Primary Biliary CholangitisPrimary Biliary CholangitisDrug: APD334Arena PharmaceuticalsNot recruiting18 Years80 YearsAll2Phase 2United States;Australia;New Zealand
22NCT03301506December 12, 201728 October 2019Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)Primary Biliary CirrhosisDrug: Seladelpar 2 mg Capsule;Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg CapsuleCymaBay Therapeutics, Inc.Recruiting18 Years75 YearsAll356Phase 2/Phase 3United States;Canada;Germany;United Kingdom
23EUCTR2014-001438-27-ES29/11/20175 June 2018The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCHPrimary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezalip
Pharmaceutical Form: Coated tablet
INN or Proposed INN: BEZAFIBRATE
CAS Number: 41859-67-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Academic Medical CenterAuthorisedFemale: yes
Male: yes
84Phase 2Spain;Netherlands
24EUCTR2016-004599-23-DE19/09/201730 April 2019A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphatasePrimary Biliary Cholangitis
MedDRA version: 20.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GKT137831
CAS Number: 1218942-37-0
Other descriptive name: GKT137831
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Genkyotex SANot Recruiting Female: yes
Male: yes
102Phase 2United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
25NCT03112681August 18, 201722 July 2019Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary CholangitisA Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )Primary Biliary CirrhosisDrug: Saroglitazar magnesium 2 mg;Drug: Saroglitazar magnesium 4 mg;Drug: Placebo Oral TabletZydus Discovery DMCCRecruiting18 Years75 YearsAll36Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-004599-23-ES26/07/201721 August 2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphatasePrimary Biliary Cholangitis
MedDRA version: 20.0 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
Pharmaceutical Form: Capsule
INN or Proposed INN: GKT137831
CAS Number: 1218942-37-0
Other descriptive name: GKT137831
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Genkyotex SAAuthorisedFemale: yes
Male: yes
102Phase 2United Kingdom;Italy;Germany;Israel;Spain;Belgium;Canada;Greece;United States
27EUCTR2016-002965-67-NL07/07/201717 July 2017A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteersAn open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILEPrimary biliairy cholangitis (PBC) Non-alcoholic steatohepatitis (NASH)
MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
Pharmaceutical Form: Tablet
AMCAuthorisedFemale: yes
Male: yes
Phase 2Netherlands
28NCT03226067June 26, 201722 October 2019Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid.A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline PhosphatasePrimary Biliary CirrhosisDrug: Placebo oral capsule;Drug: GKT137831Genkyotex SANot recruiting18 Years80 YearsAll111Phase 2United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom
29EUCTR2016-003817-80-GB31/05/201728 February 2019Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBCA Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidPrimary biliary cholangitis
MedDRA version: 20.0 Level: LLT Classification code 10034176 Term: PBC System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Elafibranor
Product Code: GFT505
Pharmaceutical Form: Tablet
INN or Proposed INN: Elafibranor
CAS Number: 824932-88-9
Current Sponsor code: GFT505
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Elafibranor
Product Code: GFT505
Pharmaceutical Form: Tablet
INN or Proposed INN: Elafibranor
CAS Number: 824932-88-9
Current Sponsor code: GFT505
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Genfit SANot Recruiting Female: yes
Male: yes
45Phase 2France;United States;Spain;Germany;United Kingdom
30NCT03092765May 29, 201714 January 2019Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidA Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidPrimary Biliary CholangitisDrug: E6011;Drug: PlaceboEA Pharma Co., Ltd.Not recruiting20 Years74 YearsAll29Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03188146May 1, 201711 March 2019Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic AcidPerformance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic AcidPrimary Biliary Cholangitis (PBC)Drug: Ursodeoxycholic AcidHumanity and Health Research CentreBeijing 302 HospitalRecruiting18 Years85 YearsAll500Phase 3China
32NCT03124108April 5, 20177 October 2019Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic AcidPrimary Biliary Cholangitis (PBC)Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: PlaceboGenfitNot recruiting18 Years75 YearsAll45Phase 2United States;France;Germany;Spain;United Kingdom
33EUCTR2016-002996-91-DE21/02/20173 September 2018A 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 928821-40-3
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
CymaBay Therapeutics, Inc.AuthorisedFemale: yes
Male: yes
128Phase 2United States;Canada;Germany;United Kingdom
34EUCTR2016-002416-41-ES17/02/201713 March 2017Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis. (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response).Primary biliary cholangitis (PBC)
MedDRA version: 19.0 Level: PT Classification code 10008604 Term: Cholangitis System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0 Level: PT Classification code 10037087 Term: Pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
Pharmaceutical Form: Tablet
INN or Proposed INN: GSK2330672
CAS Number: 1345983-37-0
Current Sponsor code: GSK2330672
Other descriptive name: GSK2330672
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: GSK2330672
Product Code: GSK2330672
Pharmaceutical Form: Tablet
INN or Proposed INN: GSK2330672
CAS Number: 1345983-37-0
Current Sponsor code: GSK2330672
Other descriptive name: GSK2330672
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline, S.A.AuthorisedFemale: yes
Male: yes
150Phase 2France;United States;Canada;Spain;Australia;Netherlands;Japan;United Kingdom
35NCT03082937January 31, 201716 December 2017An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy SubjectsAn Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male SubjectsOrphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary CirrhosisDrug: 3 mg [14C]-A4250 capsuleAlbireoNot recruiting30 Years65 YearsMale6Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-002996-91-GB12/01/201728 February 2019A 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Seladelpar
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Seladelpar
CAS Number: 928821-40-3
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Seladelpar
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Seladelpar
Product Code: MBX-8025
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Seladelpar
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
CymaBay Therapeutics, Inc.Authorised Female: yes
Male: yes
128Phase 2United States;Canada;Germany;United Kingdom
37NCT02966834January 11, 20174 November 2019Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary CholangitisA Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)CholestasisDrug: Placebo;Drug: GSK2330672GlaxoSmithKlineNot recruiting18 Years80 YearsAll140Phase 2United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom
38NCT02943447December 1, 201630 September 2019Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without CirrhosisA Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Biliary Cholangitis Without CirrhosisPrimary Biliary CholangitisDrug: Cilofexor;Drug: Placebo to match CilofexorGilead SciencesNot recruiting18 Years70 YearsAll71Phase 2United States;Austria;Canada;United Kingdom
39NCT02936596December 20164 March 2019Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap SyndromeBiochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive AgentsHepatitis, Autoimmune;Cholangitis;Liver Cirrhosis, Biliary;CholestasisDrug: Ursodeoxycholic acid combination of immunosuppressive agents;Drug: Ursodeoxycholic AcidXiaoli FanRecruiting18 Years75 YearsAll53N/AChina
40NCT03489889December 201622 October 2018Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of MedicineDevelopment of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of MedicineUrsodeoxycholic Acid;Primary Biliary CirrhosisDrug: Ursodeoxycholic Acid 300mg tablet;Drug: Ursodeoxycholic Acid 300mg capsuleUniversity of Sao Paulo General HospitalNot recruiting18 YearsN/AAll30N/ABrazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
41NCT02955602November 28, 20162 July 2018Seladelpar (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 10 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 2 mg CapsuleCymaBay Therapeutics, Inc.Not recruiting18 Years75 YearsAll116Phase 2United States;Canada;Germany;United Kingdom
42NCT02937012October 201611 June 2018Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-respondersEfficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled TrialPrimary Biliary CirrhosisDrug: Bezafibrate;Drug: Ursodeoxycholic Acid;Drug: Placebo (for Bezafibrate)Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting18 Years65 YearsAll34Phase 3Mexico
43NCT02931513September 20165 November 2018sCD163 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 AarhusRecruiting18 YearsN/AAll40Phase 2Denmark
44NCT03253276May 19, 201611 November 2019Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CTEffect of Obeticholic Acid (INT-747, Intercept) on the Hepatobiliary Transport of Bile Acids in Patients With PBC Examined by 11C-cholyl-sarcosine PET/CTPrimary Biliary CirrhosisDrug: Obeticholic acid;Drug: PlacebosUniversity of AarhusNot recruiting18 Years85 YearsAll8Early Phase 1Denmark
45NCT02701166February 201611 April 2016The Effect of Bezafibrate on Cholestatic ItchThe Effect of Bezafibrate on Cholestatic ItchPrimary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing CholangitisDrug: Bezafibrate;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico HumanitasRecruiting18 YearsN/ABoth84Phase 3Netherlands;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02823353January 201621 July 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 DiseasesRecruiting18 Years70 YearsBoth200Phase 3China
47NCT02823366January 201621 July 2016Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCAXijing Hospital of Digestive DiseasesRecruiting18 Years70 YearsBoth200Phase 3China
48NCT02916290January 201610 October 2016Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesRecruiting18 Years70 YearsBoth200Phase 3China
49NCT02916641January 201610 October 2016Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesRecruiting18 Years70 YearsBoth200Phase 3China
50NCT02965911January 201628 November 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 HospitalRecruiting18 Years65 YearsBoth72Phase 1/Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
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PhaseCountries
51EUCTR2015-002698-39-GB11/11/201518 April 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
Pharmaceutical Form: Capsule, hard
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: MBX 8025
Product Code: MBX 8025
Pharmaceutical Form: Capsule, hard
CAS Number: 928821-40-3
Current Sponsor code: MBX-8025
Other descriptive name: MBX-8025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
CymaBay Therapeutics Inc.AuthorisedFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
52NCT02557360November 201516 December 2017Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary CirrhosisEffectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDietary Supplement: S-adenosyl-L-methioninePomeranian Medical University SzczecinLaval UniversityNot recruitingN/AN/AAll24Phase 4Poland
53NCT02516605September 9, 20159 October 2018A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC PatientsA Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary CholangitisPrimary Biliary CholangitisDrug: Part 1: LJN452;Drug: Part 1: Placebo;Drug: Part 2: LJN452 Dose level 1;Drug: Part 2: Placebo;Drug: Part 2: LJN452 Dose level 2Novartis PharmaceuticalsNot recruiting18 YearsN/AAll61Phase 2United States;Canada;Germany;Poland;Russian Federation;United Kingdom
54EUCTR2014-001438-27-NL19/08/201514 September 2015The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCHPrimary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezalip
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Academic Medical CenterAuthorisedFemale: yes
Male: yes
84Netherlands
55NCT02193360May 20155 September 2016Pilot Study of FFP104 Dose Escalation in PBC SubjectsA Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed With Primary Biliary Cirrhosis (PBC)Primary Biliary CirrhosisDrug: FFP104Fast Forward PharmaceuticalsRecruiting18 Years75 YearsBoth24Phase 1/Phase 2Netherlands;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
56NCT02321306May 20151 April 2019An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary CirrhosisAn Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: LUM001Mirum Pharmaceuticals, Inc.Not recruiting18 YearsN/AAll0Phase 2United States;United Kingdom
57NCT02360852January 201516 December 2017IBAT Inhibitor A4250 for Cholestatic PruritusAn Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250 in Patients With Primary Biliary Cirrhosis and Cholestatic PruritusBiliary Cirrhosis, PrimaryDrug: A4250Sahlgrenska University Hospital, SwedenAlbireoNot recruiting18 Years80 YearsAll9Phase 2Sweden
58EUCTR2014-004070-42-SE09/12/20146 January 2015Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic PruritusAn Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic PruritusPrimary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: A4250
Pharmaceutical Form: Capsule
Sahlgrenska AcademyAuthorisedFemale: yes
Male: yes
Phase 2aSweden
59NCT02308111December 201422 October 2019Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary CholangitisA Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary CholangitisLiver Cirrhosis, BiliaryDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsRecruiting18 YearsN/AAll428Phase 4United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro
60NCT02078882September 201422 October 2018Study of Abatacept (Orencia) to Treat Primary Biliary CirrhosisAbatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic AcidPrimary Biliary CirrhosisBiological: abataceptChristopher Bowlus, MDBristol-Myers SquibbNot recruiting18 YearsN/AAll16Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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gender
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size
PhaseCountries
61NCT02135536May 201416 December 2017Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary CirrhosisA Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103Primary Biliary CirrhosisBiological: NGM282NGM Biopharmaceuticals, IncNGM Biopharmaceuticals Australia Pty LtdNot recruiting18 Years75 YearsAll36Phase 2United States;Australia;New Zealand
62NCT01899703March 10, 201416 December 2017A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2330672 Administration in Patients With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusCholestasis, IntrahepaticDrug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acidGlaxoSmithKlineNot recruiting18 Years75 YearsAll22Phase 2United Kingdom
63JPRN-UMIN0000127822014/02/012 April 2019Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Group A; phenylbutyrate 6g (Child 100mg/kg)/day *7days
Group B; phenylbutyrate 6g (Child 100mg/kg)/day *3days and 12g (Child 200mg/kg)/day *4days
Group C; phenylbutyrate 6g (Child 100mg/kg)/day *1day, phenylbutyrate 12g (Child 200mg/kg)/day *2days and phenylbutyrate 21g (Child 300mg/kg)/day *4days
Juntendo UniversityNot RecruitingNot applicableNot applicableMale and Female2Not selectedJapan
64NCT02026401February 201416 December 2017Phase 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 LtdNot recruiting18 Years75 YearsAll45Phase 2United States;Australia
65JPRN-UMIN0000124892013/12/042 April 2019Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosisOsteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 monthsFor osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. PBC patients who do not meet osteoporosis treatment criteria will be followed.Juntendo University School of MedicineNot Recruiting20years-oldNot applicableMale and Female20Not applicableJapan
No.TrialIDDate_
enrollement
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PhaseCountries
66JPRN-UMIN0000121932013/11/012 April 2019Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosisOsteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonateDiscontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
Juntendo University School of MedicineNot Recruiting20years-oldNot applicableMale and Female60Not applicableJapan
67NCT01865812November 201311 June 2018Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary CirrhosisA Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: obeticholic acid (OCA)Intercept PharmaceuticalsNot recruiting18 YearsN/AAll26Phase 2United States
68EUCTR2013-000482-36-GB08/07/20134 August 2015Phase 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 STUDYPrimary 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 fifth to 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
Pharmaceutical Form: Tablet
INN or Proposed INN: LUM001
Current Sponsor code: LUM001
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Lumena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
60Phase 2United States;United Kingdom
69NCT02963077July 201328 November 2016A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy SubjectsOrphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille SyndromeDrug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: PlaceboAlbireoNot recruiting18 Years60 YearsBoth94Phase 1
70NCT01879735June 201319 October 2017Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CTHepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CTCholestasis;Primary Sclerosing Cholangitis;Primary Biliary CirrhosisDrug: 11C-CSar;Drug: ICGUniversity of AarhusNot recruiting18 YearsN/AAll22Phase 1Denmark
No.TrialIDDate_
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71JPRN-UMIN0000157892012/11/302 April 2019Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantationnon-compenzated liver cirrhosis(HBV,HCV, alcoholic, etc), primary biliary cirrhosis (PBC), primary screlosing cholangitis (PSC), hepatocellular carcinoma (HCC within Milan criteria), non-alcoholic steatohepatitis (NASH), othersThe patient is given cyclophosphamide (40mg/kg,iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with comventioal method. Tke immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. the immunosuppressant is completely discontinued by 18 months after transplantation.Traslational Research and Clinical Trial CenterRecruiting18years-old65years-oldMale and Female10Phase 1,2Japan
72NCT01654731October 15, 201210 September 2018Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisMulticenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy.PBCDrug: Bezafibrate;Drug: placeboAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll100Phase 3France
73EUCTR2012-000145-12-GB15/08/201230 April 2019Pilot study of Rituximab for the treatment of fatigue in PBCRituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC) - RITPBC StudySevere fatigue in Primary Biliary Cirrhosis
MedDRA version: 18.0 Level: PT Classification code 10004661 Term: Biliary cirrhosis primary System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: MabThera®
Product Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
The Newcastle upon Tyne Hospitals NHS Foundation TrustNot Recruiting Female: yes
Male: yes
58Phase 2United Kingdom
74NCT01614405June 201214 December 2015Highly Active Antiretroviral Therapy for Patients With Primary Biliary CirrhosisRandomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Truvada and KaletraUniversity of AlbertaAbbott;Gilead Sciences;Canadian Institutes of Health Research (CIHR)Not recruiting18 YearsN/ABoth13N/ACanada
75EUCTR2011-004728-36-SE16/04/201230 April 2019A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary CirrhosisPrimary biliary cirrhosis
MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
Pharmaceutical Form: Tablet
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: OCA, 6-ECDCA or INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
Pharmaceutical Form: Tablet
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: OCA, 6-ECDCA or INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Intercept Pharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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76EUCTR2011-004728-36-BE30/03/201230 April 2019A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary CirrhosisPrimary biliary cirrhosis
MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
Pharmaceutical Form: Tablet
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: OCA, 6-ECDCA or INT-747
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
Pharmaceutical Form: Tablet
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: OCA, 6-ECDCA or INT-747
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Intercept Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
77NCT01473524January 201223 April 2019Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary CirrhosisA Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsNot recruiting18 YearsN/AAll217Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom
78NCT01430429December 201119 February 2015Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal AntibodyAn 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 PBC Patients With an Incomplete Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: NI-0801NovImmune SANot recruiting18 YearsN/ABothPhase 2Italy;United Kingdom
79EUCTR2011-004681-15-AT09/11/20119 December 2013Effects 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 PBCUp 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BEZAFIBRATE
CAS Number: 41859-67-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Product Name: Ursodeoxycholsäure
Pharmaceutical Form: Capsule
CAS Number: 128-13-2
Other descriptive name: URSODEOXYCHOLIC ACID
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Medizinische Universität GrazNot RecruitingFemale: yes
Male: yes
Austria
80NCT01440309November 201119 February 2015Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary CirrhosisPhase I Clinical Trial, Randomized, Controlled, to Evaluate the Efficacy and Safety of Therapy With Allogenic Mesenchymal Stem Cells From Bone Marrow for Patients With Refractory Primary Biliary CirrhosisPrimary Biliary CirrhosisBiological: Biological: mesenchymal stem cell;Drug: ursodeoxycholic acidRobert Chunhua Zhao, MD, PhDPeking Union Medical College HospitalRecruiting18 Years60 YearsBoth20Phase 1China
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
81NCT01389973September 201119 October 2017A 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, LLCNot recruiting18 Years99 YearsAll20Phase 2United States;Canada
82NCT01603199September 201120 June 2016High-protein High-fiber Diet in Patients With Primary Biliary CirrhosisImpact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDietary Supplement: High protein high fiber dietInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNot recruiting18 Years70 YearsBoth36N/AMexico
83EUCTR2011-001326-26-IT21/06/201129 October 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. - PIANOProven 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 Level: SOC 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
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: NI-0801
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
NOVIMMUNE BVNot RecruitingFemale: yes
Male: yes
40Italy
84EUCTR2011-001326-26-GB27/05/20115 November 2012Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody.PIANO. 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. - PIANOPrimary biliary cirrhosis
MedDRA version: 14.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: NI-0801
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: NI-0801
Other descriptive name: fully human monoclonal antibody directed against CXCL10
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
NovImmune S.A.Not RecruitingFemale: yes
Male: yes
Italy;United Kingdom
85NCT01141296April 201119 February 2015Fenofibrate 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 ClinicNot recruiting21 Years75 YearsBoth0Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
86NCT01249092November 201019 October 2017Pentoxifylline for Primary Biliary CirrhosisA Pilot Study of Pentoxifylline for the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: PentoxifyllineThe Cleveland ClinicNot recruiting18 Years76 YearsAll20Phase 2United States
87JPRN-UMIN0000038022010/04/012 April 2019Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.phenylbutyrate(Child 250mg/kg/day)for 1-4months : phenylbutyrate(Child 350mg/kg/day)for 1-4months : phenylbutyrate(Child 500mg/kg/day)for 1-4monthsSaiseikai Yokohama City Tobu HospitalLaboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Tokyo)RecruitingNot applicableNot applicableMale and Female15Not selectedJapan
88NCT01857284September 200919 February 2015Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary CirrhosisA Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid CapsulesBeijing Friendship HospitalBeijing Trendful Kangjian Medical Information Consulting Limited CompanyNot recruiting18 Years70 YearsBoth216Phase 3China
89NCT00943176June 200919 February 2015Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)Modafinil in the Treatment of Fatigue in Patients With Primary Biliary CirrhosisFatigue;Primary Biliary CirrhosisDrug: ModafinilMayo ClinicAmerican College of GastroenterologyNot recruiting21 Years75 YearsBoth40Phase 1United States
90EUCTR2007-001424-12-GB21/04/200910 July 2015A Study of INT 747 Monotherapy in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary CirrhosisPrimary biliary cirrhosis
MedDRA version: 18.0 Level: PT Classification code 10004661 Term: Biliary cirrhosis primary System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747 or OCA
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747 or OCA
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747 or OCA
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747 or OCA
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA)
Concentration unit: mg milligram(s)
Concentration type: equal
Intercept PharmaceuticalsAuthorisedFemale: yes
Male: yes
120France;Spain;Austria;Germany;United Kingdom
No.TrialIDDate_
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Last_Refreshed_
on
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91NCT01510860November 200820 May 2019Ursofalk 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 GmbHNot recruiting18 YearsN/AAll65Phase 4Germany
92EUCTR2007-001425-10-GB13/10/200819 March 2012A 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 CirrhosisPrimary biliary cirrhosis
MedDRA version: 9.1 Level: PT Classification code 10004661 Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: INT-747
Product Code: INT-747
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA or INT-747
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Intercept PharmaceuticalsNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
93EUCTR2007-004040-70-SE22/09/200819 February 2018Study to compare the combination of ursodeoxycholic acid and budesonide with the combination of ursodeoxycholic acid and placebo in the 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 PBCPBC 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
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Ursofalk
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: URSODEOXYCHOLIC ACID
CAS Number: 128132
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
94EUCTR2008-001524-31-DE26/08/200819 March 2012Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBCDouble-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBCTreatment of primary biliary cirrhosis
MedDRA version: 9.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis
Trade Name: Ursofalk® capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: URSODEOXYCHOLIC ACID
CAS Number: 128132
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Ursofalk® 500 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: URSODEOXYCHOLIC ACID
CAS Number: 128132
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
74Phase 4Germany;Netherlands
95EUCTR2007-004040-70-DE15/05/200825 January 2016Study to compare the combination of ursodeoxycholic acid and budesonide with the combination of ursodeoxycholic acid and placebo in the 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 PBCPBC 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
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Ursofalk
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: URSODEOXYCHOLIC ACID
CAS Number: 128132
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2006-006742-34-GB20/12/200728 February 2019The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.primary biliary cirrhosis
MedDRA version: 9.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis
Trade Name: Ezetrol
Product Name: Ezetimibe
Product Code: EZT
Pharmaceutical Form: Tablet
INN or Proposed INN: EZETIMIBE
CAS Number: 163222-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10mg-
Trade Name: pyridoxine 10mg BP
Product Name: pyridoxine 10mg
Product Code: A11HA02
Pharmaceutical Form: Tablet
INN or Proposed INN: PYRIDOXINE
CAS Number: 65236
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10MG-
Barts and The London NHS TrustNot Recruiting Female: yes
Male: yes
70Phase 4United Kingdom
97NCT00587119December 200719 February 2015Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune HepatitisOpen-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis.Primary Biliary Cirrhosis;Autoimmune HepatitisDrug: BudesonideMayo ClinicNot recruiting21 Years75 YearsBoth0N/AUnited States
98NCT00570765November 200711 June 2018Study of INT-747 as Monotherapy in Patients With PBCA Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: Placebo;Drug: INT-747Intercept PharmaceuticalsNot recruiting18 Years70 YearsAll59Phase 2United States;Austria;Canada;France;Germany;Spain;United Kingdom
99NCT00550862October 200719 October 2017Study 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 PharmaceuticalsNot recruiting18 Years70 YearsAll165Phase 2United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom
100NCT00575042August 200716 December 2017Use of Fenofibrate for Primary Biliary CirrhosisPilot Study of Fenofibrate for Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)University of FloridaThe PBCers Organization;Shionogi Inc.Not recruiting21 Years75 YearsAll20Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT00364819January 200716 December 2017Initial Study of Rituximab to Treat Primary Biliary CirrhosisEffects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: rituximabUniversity of California, DavisGenentech, Inc.Not recruiting18 Years65 YearsFemale6Phase 1/Phase 2United States
102NCT00406237December 200619 February 2015Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary CirrhosisOpen Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: tigecyclineWyeth is now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/ABoth8Phase 1United States;Puerto Rico
103EUCTR2006-003712-22-DE23/10/200628 January 2013Pharmacokinetics 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 volunteersPrimary 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ursodeoxycholic acid
CAS Number: 128-13-2
Concentration unit: mg milligram(s)
Concentration number: 500-
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
24Germany
104NCT00805805April 200616 December 2017Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary CirrhosisPhase III Trial of Tetrathiomolybdate (TM) in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Tetrathiomolybdate;Other: PlaceboGeorge BrewerFDA Office of Orphan Products DevelopmentNot recruiting18 YearsN/AAll29Phase 3United States
105NCT00393185January 200619 February 2015Stem Cell Transplantation in Patients With Primary Biliary CirrhosisNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis: A Phase I StudyPrimary Biliary CirrhosisBiological: Non-myeloablative Hematopoietic Stem Cell TransplantationRichard Burt, MDNorthwestern Memorial HospitalNot recruiting18 Years55 YearsBoth0Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00844402January 200619 February 2015Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary CirrhosisSafety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary CirrhosisPrimary Biliary Cirrhosis;HypercholesterolemiaDrug: AtorvastatinMedical University of GrazNot recruiting18 Years70 YearsBoth40Phase 3Austria
107EUCTR2005-002160-28-AT23/09/200520 May 2013Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosisSafety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosisReduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question whether long-term treatment with statins may have potential beneficial effects on the course of PBC.Trade Name: Sortis
Product Name: Sortis 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and HepatologyNot RecruitingFemale: yes
Male: yes
80Austria
108NCT00125281July 25, 200516 December 2017SAMe to Treat Biliary Cirrhosis SymptomsS-Adenosyl Methionine for Symptomatic Treatment of Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: S-adenosyl-methionine (SAMe) capsulesNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting21 YearsN/AAll50Phase 2United States
109NCT00490620January 200419 February 2015Study of Combivir for Patients With Primary Biliary CirrhosisRandomized Controlled Pilot Study of Combivir for Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Combination antiviral therapy;Drug: PlaceboUniversity of AlbertaGlaxoSmithKline;Axcan PharmaNot recruiting18 Years75 YearsBoth59Phase 2/Phase 3United States;Canada;United Kingdom
110JPRN-C0000002252003/12/012 April 2019Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosisPrimary 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 GroupNot Recruiting20years-old85years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT00588302June 200319 February 2015Moexipril for Primary Biliary CirrhosisOpen-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC)Primary Biliary CirrhosisDrug: MoexiprilMayo ClinicUCB PharmaNot recruiting18 Years85 YearsBoth20Phase 2United States
112NCT00004784January 199419 February 2015Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: methotrexate;Drug: ursodiolNational Center for Research Resources (NCRR)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of TexasNot recruiting20 Years69 YearsBoth315Phase 3
113NCT00006168January 199419 February 2015Ursodiol-Methotrexate for Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: MethotrexateNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting20 Years69 YearsBothPhase 3United States
114NCT00004748November 198919 February 2015Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary CirrhosisPhase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: colchicine;Drug: methotrexate;Drug: ursodiolNational Center for Research Resources (NCRR)Tufts Medical CenterNot recruitingN/AN/ABoth90Phase 3

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