93. 原発性胆汁性胆管炎 [臨床試験数:230,薬物数:215(DrugBank:51),標的遺伝子数:34,標的パスウェイ数:107

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000037243
2021-01-012020-08-27Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MSClinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS primary biliary cholangitisexperimental group:Yuyinyanggan decoction+Ursodeoxycholic Acid Capsules;control group:placebo of Yuyinyanggan decoction +Ursodeoxycholic Acid Capsules ;Shanghai Municipal Hospital of Traditional Chinese MedicineNULLPendingBothexperimental group:96;control group:96;China
2NCT04620733
(ClinicalTrials.gov)
January 20214/11/2020RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mgCymaBay Therapeutics, Inc.NULLNot yet recruiting18 Years75 YearsAll180Phase 3NULL
3NCT04604652
(ClinicalTrials.gov)
November 30, 202016/10/2020Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary CholangitisA Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBCPrimary Biliary Cholangitis;Primary Biliary Cirrhosis;Cholangitis;Cholestasis;Biliary Tract Diseases;Bile Duct StrictureDrug: HTD1801 (BUDCA)HighTide Biopharma Pty LtdNULLRecruiting18 Years75 YearsAll30Phase 2United States
4EUCTR2020-001961-34-HU
(EUCTR)
16/11/202017/09/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary
5NCT04618575
(ClinicalTrials.gov)
November 5, 202031/10/2020Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1Hepatitis;Primary Biliary Cholangitis;AutoimmuneDrug: Ursodeoxycholic acid combined with total glucosides of paeony;Drug: Ursodeoxycholic acid onlyWest China HospitalNULLNot yet recruiting18 Years75 YearsAll137Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04617561
(ClinicalTrials.gov)
November 1, 202029/10/2020Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features IIUrsodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical TrialHepatitis, Autoimmune;Primary Biliary CholangitisDrug: Ursodeoxycholic acid;Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(prednisone)West China HospitalNULLNot yet recruiting18 Years70 YearsAll90Phase 4China
7EUCTR2019-004941-34-BE
(EUCTR)
09/10/202031/08/2020A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic AcidA Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid Primary Biliary Cholangitis
MedDRA version: 21.0;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
INN or Proposed INN: ELAFIBRANOR
GENFITNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Finland;Spain;Turkey;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Denmark;South Africa;Germany;Netherlands
8ChiCTR2000037244
2020-10-012020-08-27A multicenter, randomized, double-blind, Tiaomian I study of PBCA multicenter, randomized, double-blind, Tiaomian I study of PBC Primary biliary cholangitiscontrol group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I;Longhua Hospital ShangHai University of Traditional Chinese MedicineNULLRecruitingBothcontrol group:45;experimental group:45;China
9NCT04526665
(ClinicalTrials.gov)
September 24, 202021/8/2020Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Elafibranor 80mg;Drug: PlaceboGenfitNULLRecruiting18 Years75 YearsAll150Phase 3United States
10NCT03954327
(ClinicalTrials.gov)
September 20207/5/2019Combination Antiretroviral Therapy (cART) for PBCRandomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF);Drug: Raltegravir;Drug: Placebo Oral Capsule [CEBOCAP]University of AlbertaMerck Sharp & Dohme Corp.Not yet recruiting18 YearsN/AAll60Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004011-44-GB
(EUCTR)
10/08/202028/05/2020Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC studyA randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus. - TURRIFIC Protocol Version 8 Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.
MedDRA version: 20.1;Level: PT;Classification code 10049055;Term: Cholestasis of pregnancy;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.1;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: Rifampicin
INN or Proposed INN: Rifampicin
Product Name: Ursodeoxycholic acid
INN or Proposed INN: Ursodeoxycholic acid
The University Of AdelaideNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
108Phase 3Finland;Australia;Netherlands;United Kingdom;Sweden
12EUCTR2018-002575-17-AT
(EUCTR)
20/07/202007/04/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
13NCT04167358
(ClinicalTrials.gov)
July 14, 202015/11/2019Linerixibat Long-term Safety and Tolerability StudyLong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary CholangitisCholestasisDrug: LinerixibatGlaxoSmithKlineNULLRecruiting18 Years90 YearsAll75Phase 3United States;Canada;Germany;Japan;Poland;Spain
14EUCTR2019-003158-10-PL
(EUCTR)
22/06/202027/03/2020Linerixibat Long-term Safety and Tolerability StudyLong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Poland;United Kingdom;Japan
15EUCTR2018-002575-17-HR
(EUCTR)
05/06/202025/06/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-003158-10-GB
(EUCTR)
04/06/202004/02/2020Linerixibat Long-term Safety and Tolerability StudyLong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Poland;Japan;United Kingdom
17NCT04376528
(ClinicalTrials.gov)
May 30, 20203/5/2020Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard TherapyMycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard TherapyHepatitis, Autoimmune;Primary Biliary Cholangitis;ImmunosuppressionDrug: Cyclosporin A;Drug: Mycophenolate MofetilWest China HospitalNULLNot yet recruiting18 Years70 YearsAll89Phase 4NULL
18EUCTR2018-004011-44-FI
(EUCTR)
20/05/202026/09/2019Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC studyA randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritis. - TURRIFIC Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]Product Name: Rifampicin
Product Name: Ursodeoxycholic acid
The University of AdelaideNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
108Phase 4Finland;Australia;Netherlands;United Kingdom;Sweden
19EUCTR2018-002575-17-PL
(EUCTR)
05/05/202009/01/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
20ChiCTR2000032053
2020-05-012020-04-19Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC)Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) primary biliary cholangitisGold Standard:Any two of the following items met:
1. increased biochemical indicators of cholestasis such as alkaline phosphatase;
2. positive serum AMA or AMA-M2;
3. hepatic histopathology.;Index test:high-frequency and low-frequency ultrasound?transient elastography (TE);
You'an Hospital, Capital Medical UniversityNULLPending1870BothTarget condition:100;Difficult condition:270N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04650243
(ClinicalTrials.gov)
March 21, 202027/4/2020Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary CholangitisClinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary CholangitisPrimary Biliary CholangitisDrug: ursodeoxycholic acidPeking Union Medical College HospitalNULLRecruiting18 Years65 YearsAll90Phase 4China
22NCT04278820
(ClinicalTrials.gov)
March 20, 202018/1/2020A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of TQA3526 in the Treatment of Naive or Previously Treated PBC PatientsPrimary Biliary CirrhosisDrug: TQA3526;Drug: Placebo to match TQA3526Chia Tai Tianqing Pharmaceutical Group Co., Ltd.NULLNot yet recruiting18 Years70 YearsAll130Phase 2China
23JPRN-UMIN000039350
2020/03/0101/03/2020Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemiaClinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia - Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia primary biliary cholangitispemafibrate for 12 months

bezafibrate for 12 months
Shinshu University Faculty of Medicine, Department of GastroenterologyNULLPending20years-old95years-oldMale and Female60Not selectedJapan
24EUCTR2018-002575-17-CZ
(EUCTR)
27/02/202016/10/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
25EUCTR2018-002575-17-GB
(EUCTR)
14/02/202019/08/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-002575-17-GR
(EUCTR)
14/02/202005/11/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
27NCT03521297
(ClinicalTrials.gov)
January 20, 202028/4/2018Probiotics in PBC Patients of Poor Response to UDCASafety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) ResponsePrimary Biliary Cholangitis (PBC)Drug: Probiotic;Dietary Supplement: PlaceboSun Yat-sen UniversityNULLNot yet recruiting18 Years70 YearsAll60Phase 2China
28EUCTR2018-002575-17-LT
(EUCTR)
17/01/202017/10/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
29EUCTR2018-002575-17-SK
(EUCTR)
04/12/201920/09/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Croatia;Australia;Denmark;Georgia;Norway;Netherlands;Germany;Korea, Republic of;Sweden
30ChiCTR1900026813
2019-11-302019-10-23Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western MedicineStudy for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine primary biliary cholangitisTreatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA;Longhua Hospital, Shanghai University of traditional Chinese MedicineNULLPending1865BothTreatment group :120;Control group:120;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31ChiCTR1900027043
2019-11-302019-10-29A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosisA multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis primary biliary cirrhosisExperimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA;Longhua Hospital, Shanghai University of Traditional Chinese MedicineNULLRecruiting1865BothExperimental group:136;Control group:136;China
32EUCTR2018-002575-17-ES
(EUCTR)
15/10/201926/07/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary BiliaryCholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Germany;Norway;Sweden
33EUCTR2018-002575-17-FR
(EUCTR)
14/10/201909/07/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
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]
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Norway;Sweden
34NCT04594694
(ClinicalTrials.gov)
October 2, 201914/7/2020Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Patients With PBCA Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic AcidLiver Cirrhosis, BiliaryDrug: Obeticholic acid;Drug: Bezafibrate 200 MG;Drug: OCA Placebo;Drug: Bezafibrate 200 mg Placebo;Drug: Bezafibrate 400 MG;Drug: Bezafibrate 400 mg PlaceboIntercept PharmaceuticalsNULLRecruiting18 YearsN/AAll72Phase 2Belgium;Croatia;Czechia;Hungary;Korea, Republic of;Spain
35NCT04076527
(ClinicalTrials.gov)
September 201929/8/2019Prospective, Multicenter Cohort Study on Primary Biliary CholangitisProspective, Multicenter Cohort Study on Primary Biliary CholangitisPBC;Primary Biliary CholangitisDrug: UDCA;Drug: OcalivaUniversity of LeipzigRWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical SchoolNot yet recruiting18 YearsN/AAll1200Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04047160
(ClinicalTrials.gov)
August 29, 201930/7/2019Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)An Open-Label, Dose-Finding Study for the CBP / ß-catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I)Primary Biliary Cholangitis (PBC);Liver Cirrhosis, BiliaryDrug: OP-724Kiminori Kimura, MDOHARA Pharmaceutical Co., Ltd.;Japan Agency for Medical Research and DevelopmentRecruiting20 Years74 YearsAll12Phase 1Japan
37NCT04522869
(ClinicalTrials.gov)
August 10, 20194/9/2019Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary AtresiaEvaluation Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Liver Cirrhosis Due to Biliary Atresia: A Matched Control Prospective StudyPrimary Biliary CirrhosisBiological: Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) TransplantationVinmec Research Institute of Stem Cell and Gene TechnologyChildren's Hospital Number 2, Ho Chi Minh City, VietnamRecruiting5 Months2 YearsAll34Phase 1/Phase 2Vietnam
38ChiCTR1900024836
2019-07-302019-07-30Exploration of non-invasive diagnostic model of liver fibrosis based on artificial intelligence in primary biliary cholangitis Clinical research protocolExploration of non-invasive diagnostic model of liver fibrosis based on artificial intelligence in primary biliary cholangitis Clinical research protocol Primary biliary cholangitisGold Standard:Liver biopsy pathology.;Index test:Non-invasive diagnostic model for liver fibrosis: including AST/PLT value index (APRI model), Forns model, S index, and based on this, a new non-invasive liver fibrosis diagnosis model is generated.;Beijing You'an Hospital, Capital Medical UniversityNULLRecruiting1880BothTarget condition:180;Difficult condition:180China
39EUCTR2018-002575-17-HU
(EUCTR)
25/07/201904/06/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
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]
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGreece;Finland;Spain;Ireland;Austria;Israel;United Kingdom;France;Hungary;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Korea, Republic of;Sweden
40NCT03995212
(ClinicalTrials.gov)
June 25, 201919/6/2019Study 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.NULLRecruiting18 Years80 YearsAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-003365-34-GB
(EUCTR)
02/05/201911/02/2019A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAA Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA Primary Biliary Cholangitis
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Italy;United Kingdom
42EUCTR2018-001171-20-AT
(EUCTR)
29/04/201919/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
43EUCTR2018-001171-20-NL
(EUCTR)
18/04/201916/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
44NCT03742973
(ClinicalTrials.gov)
March 28, 201914/11/2018A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAA Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCAPrimary Biliary CholangitisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLTerminated18 YearsN/AAll2Phase 2United States;Puerto Rico;Italy;United Kingdom
45EUCTR2018-001171-20-BE
(EUCTR)
06/03/201929/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2018-001171-20-FR
(EUCTR)
23/01/201918/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
47EUCTR2017-003528-62-BE
(EUCTR)
11/01/201924/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
48EUCTR2017-001762-13-LT
(EUCTR)
31/12/201825/10/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 Impairment Primary 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
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany
49EUCTR2018-001171-20-PL
(EUCTR)
27/12/201806/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
50EUCTR2018-001171-20-ES
(EUCTR)
21/12/201818/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2018-001171-20-DE
(EUCTR)
20/12/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
52ChiCTR1800020160
2018-12-202018-12-18Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosisClinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis Primary Biliary Cirrhosis1:Fenofibrate+UDCA;2:UDCA;Peking Union Medical College HosipitalNULLRecruiting1865Both1:20;2:20;China
53EUCTR2017-003528-62-DE
(EUCTR)
05/12/201816/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
54EUCTR2017-001762-13-EE
(EUCTR)
04/12/201815/10/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 Impairment Primary 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
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
55EUCTR2017-003528-62-NL
(EUCTR)
29/11/201809/07/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2017-001762-13-DE
(EUCTR)
27/11/201827/06/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 Impairment Primary 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
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany
57NCT03602560
(ClinicalTrials.gov)
November 26, 201818/7/2018ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: PlaceboCymaBay Therapeutics, Inc.NULLSuspended18 Years75 YearsAll240Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom
58EUCTR2018-001171-20-HU
(EUCTR)
26/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
59EUCTR2018-001171-20-GR
(EUCTR)
23/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
60EUCTR2017-001762-13-BE
(EUCTR)
24/10/201814/08/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 Impairment Primary 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
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-003528-62-AT
(EUCTR)
19/10/201825/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Enanta Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
119 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Australia;Austria;Netherlands;Germany;United Kingdom
62EUCTR2017-001762-13-HU
(EUCTR)
28/08/201829/08/2018 A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
63EUCTR2017-003528-62-ES
(EUCTR)
28/08/201824/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
64EUCTR2017-001762-13-ES
(EUCTR)
01/08/201820/06/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 Impairment Primary 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
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
65EUCTR2017-003528-62-GB
(EUCTR)
27/07/201822/05/2018A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA).A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID Primary Biliary Cholangitis (PBC)
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Product Name: EDP-305
Product Code: EDP-305
INN or Proposed INN: EDP-305
Enanta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03633227
(ClinicalTrials.gov)
June 22, 20188/4/2018Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic ImpairmentA 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 ImpairmentLiver Cirrhosis, BiliaryDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsNULLActive, not recruiting18 Years85 YearsAll50Phase 4United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain
67EUCTR2016-003817-80-FR
(EUCTR)
09/05/201808/03/2018Phase 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 and Inadequate Response to Ursodeoxycholic Acid Primary 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
INN or Proposed INN: Elafibranor
Product Name: Elafibranor
Product Code: GFT505
INN or Proposed INN: Elafibranor
Genfit SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Spain;Germany;United Kingdom
68NCT03476993
(ClinicalTrials.gov)
April 27, 201820/3/2018Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary CholangitisOpen-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary CholangitisLiver Cirrhosis, BiliaryBiological: BCD-085BiocadNULLTerminated18 Years60 YearsAll9Phase 2Russian Federation
69JPRN-UMIN000031384
2018/03/1620/02/2018Efficacy 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
70EUCTR2017-003910-16-GB
(EUCTR)
08/02/201815/11/2017A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitisAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Seladelpar
Product Code: MBX-8025, DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, Formulation 2
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, Formulation 2
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3;Phase 4Serbia;United States;Greece;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03345589
(ClinicalTrials.gov)
January 30, 20186/11/2017A 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 HospitalNULLUnknown status18 Years70 YearsAll40Phase 4China
72EUCTR2017-003910-16-DE
(EUCTR)
29/01/201804/12/2017A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitisAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis
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]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
73EUCTR2014-005012-42-PT
(EUCTR)
08/01/201829/08/2017A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
74NCT03665519
(ClinicalTrials.gov)
January 3, 20186/9/2018Clinical 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 CirrhosisDietary Supplement: Sublimated mare milk;Drug: Ursodeoxycholic AcidNational Scientific Medical Center, KazakhstanEurasia Invest Ltd.;Ministry of Education and Science, Republic of KazakhstanActive, not recruiting18 Years75 YearsAll40N/AKazakhstan
75NCT03394924
(ClinicalTrials.gov)
December 27, 201723/12/2017A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary CholangitisA Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: PlaceboEnanta PharmaceuticalsPharmaceutical Research Associates;Triangle BiostatisticsCompleted18 Years75 YearsAll68Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03155932
(ClinicalTrials.gov)
December 15, 201711/5/2017Safety, 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 PharmaceuticalsNULLTerminated18 Years80 YearsAll2Phase 2United States;Australia;New Zealand
77NCT03301506
(ClinicalTrials.gov)
December 12, 201726/9/2017Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)ASSURE: 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 5 mg Capsule;Drug: Seladelpar 10 mg CapsuleCymaBay Therapeutics, Inc.NULLActive, not recruiting18 Years75 YearsAll500Phase 3United States;Canada;Germany;United Kingdom
78EUCTR2014-001438-27-ES
(EUCTR)
29/11/201710/10/2017The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCH Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Academic Medical CenterNULLNot Recruiting Female: yes
Male: yes
84 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Netherlands
79EUCTR2016-002416-41-PL
(EUCTR)
14/11/201705/09/2017Dose 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: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;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
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;France;Canada;Spain;Poland;Australia;Netherlands;United Kingdom;Japan
80EUCTR2016-004599-23-GR
(EUCTR)
27/10/201706/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81JPRN-JapicCTI-173728
05/10/201705/10/2017Pharmacokinetic study of K-877 in patients with Primary biliary cholangitisPharmacokinetic study of K-877 in patients with Primary biliary cholangitis Primary biliary cholangitisIntervention name : Pemafibrate
INN of the intervention : Pemafibrate
Dosage And administration of the intervention : Oral dose
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kowa Co., Ltd.NULLcomplete20BOTH8Phase 1Japan
82EUCTR2016-004599-23-DE
(EUCTR)
19/09/201710/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
83NCT03112681
(ClinicalTrials.gov)
August 18, 201710/4/2017Study 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 DMCCNULLActive, not recruiting18 Years75 YearsAll37Phase 2United States
84EUCTR2016-004599-23-BE
(EUCTR)
10/08/201710/04/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom
85EUCTR2016-004599-23-ES
(EUCTR)
26/07/201704/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2016-002965-67-NL
(EUCTR)
07/07/201729/03/2017A 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 - OCABILE Primary 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)
AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
87EUCTR2016-004599-23-GB
(EUCTR)
30/06/201717/05/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Genkyotex SANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
88NCT03226067
(ClinicalTrials.gov)
June 26, 201730/6/2017Study 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: GKT137831;Drug: Placebo oral capsuleGenkyotex SANULLCompleted18 Years80 YearsAll111Phase 2United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom
89EUCTR2016-003817-80-GB
(EUCTR)
31/05/201708/03/2017Phase 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 Acid Primary 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]
Genfit SANULLNot Recruiting Female: yes
Male: yes
45 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Spain;Germany;United Kingdom
90NCT03092765
(ClinicalTrials.gov)
May 29, 201724/3/2017Study 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.NULLTerminated20 Years74 YearsAll29Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-003817-80-ES
(EUCTR)
22/05/201708/03/2017Phase 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 Acid Primary biliary cholangitis
MedDRA version: 19.1;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
INN or Proposed INN: Elafibranor
Product Name: Elafibranor
Product Code: GFT505
INN or Proposed INN: Elafibranor
Genfit SANULLNot RecruitingFemale: yes
Male: yes
45Phase 2France;United States;Spain;Germany;United Kingdom
92NCT03188146
(ClinicalTrials.gov)
May 1, 20178/6/2017Performance 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 YearsAll500China
93NCT03124108
(ClinicalTrials.gov)
April 5, 201728/3/2017Study 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: PlaceboGenfitNULLCompleted18 Years75 YearsAll45Phase 2United States;France;Germany;Spain;United Kingdom
94EUCTR2016-002416-41-GB
(EUCTR)
24/03/201719/01/2017Dose 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: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;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
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Poland;Spain;Australia;Netherlands;Japan;United Kingdom
95EUCTR2014-005012-42-NL
(EUCTR)
23/02/201711/11/2015 A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). 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]
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
428 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2016-002996-91-DE
(EUCTR)
21/02/201717/11/2016A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
97EUCTR2016-002416-41-ES
(EUCTR)
17/02/201709/12/2016Dose 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;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
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2France;United States;Canada;Spain;Australia;Netherlands;Japan;United Kingdom
98EUCTR2015-001590-41-PL
(EUCTR)
09/02/201705/01/2017A 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 cholangitis - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients 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 Code: LJN452
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Product Code: LJN452
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Product Code: LJN452
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
152Phase 2United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom
99EUCTR2016-002443-42-AT
(EUCTR)
31/01/201721/12/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects 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 Cirrhosis Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Austria;United Kingdom
100NCT03082937
(ClinicalTrials.gov)
January 31, 201727/2/2017An 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 capsuleAlbireoNULLCompleted30 Years65 YearsMale6Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2016-002996-91-GB
(EUCTR)
12/01/201721/11/2016A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
102NCT02966834
(ClinicalTrials.gov)
January 11, 201715/11/2016Dose 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: GSK2330672GlaxoSmithKlineNULLCompleted18 Years80 YearsAll147Phase 2United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom
103EUCTR2016-002443-42-GB
(EUCTR)
09/01/201716/11/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects 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 Cirrhosis Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Austria;United Kingdom
104NCT02943447
(ClinicalTrials.gov)
December 1, 201613/6/2016Study to Evaluate the Safety, 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 SciencesNULLTerminated18 Years70 YearsAll71Phase 2United States;Austria;Canada;United Kingdom
105NCT03489889
(ClinicalTrials.gov)
December 201612/1/2018Development 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 HospitalNULLCompleted18 YearsN/AAll30N/ABrazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT02936596
(ClinicalTrials.gov)
December 201615/10/2016Remission 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 FanNULLRecruiting18 Years75 YearsAll53N/AChina
107NCT02955602
(ClinicalTrials.gov)
November 28, 20162/11/2016Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CirrhosisDrug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg CapsuleCymaBay Therapeutics, Inc.NULLCompleted18 Years75 YearsAll119Phase 2United States;Canada;Germany;United Kingdom
108NCT02937012
(ClinicalTrials.gov)
October 201613/10/2016Use 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 ZubiranNULLUnknown status18 Years65 YearsAll34Phase 3Mexico
109NCT02931513
(ClinicalTrials.gov)
September 201611/10/2016sCD163 in PBC Patients - Assessment of Treatment ResponseMacrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCAPrimary Biliary Cirrhosis;Liver Inflammation;Ursodeoxycholic AcidOther: Blood samples;Device: Fibroscan;Other: Questionnaires;Biological: Liver biopsyUniversity of AarhusNULLRecruiting18 YearsN/AAll40Denmark
110EUCTR2014-005012-42-BG
(EUCTR)
23/08/201606/07/2016A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT) 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]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03253276
(ClinicalTrials.gov)
May 19, 201628/5/2017Effect 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 AarhusNULLCompleted18 Years85 YearsAll8Early Phase 1Denmark
112EUCTR2015-002698-39-PL
(EUCTR)
03/03/201608/01/2016A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
113EUCTR2014-005012-42-DE
(EUCTR)
08/02/201604/01/2016A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
114NCT02701166
(ClinicalTrials.gov)
February 20162/3/2016The 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
115EUCTR2015-001590-41-DE
(EUCTR)
11/01/201613/01/2016A 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 cholangitis - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients 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 Code: LJN452, 0,01 mg
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Product Code: LJN452, 0,03 mg
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Product Code: LJN452, 0,1 mg
INN or Proposed INN: tropifexor
Other descriptive name: LJN452
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
152Phase 2United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2014-005012-42-HU
(EUCTR)
05/01/201623/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
117NCT02823366
(ClinicalTrials.gov)
January 201628/1/2016Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
118NCT02916641
(ClinicalTrials.gov)
January 201628/1/2016Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
119NCT02823353
(ClinicalTrials.gov)
January 201628/1/2016Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisFenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control StudyPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
120NCT02965911
(ClinicalTrials.gov)
January 201615/11/2016Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCAA Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCAPrimary Biliary CirrhosisDrug: Fenofibrate;Drug: UDCABeijing 302 HospitalNULLRecruiting18 Years65 YearsBoth72Phase 1/Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02916290
(ClinicalTrials.gov)
January 201628/1/2016Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Fuzhenghuayu;Drug: UDCAXijing Hospital of Digestive DiseasesNULLRecruiting18 Years70 YearsBoth200Phase 3China
122EUCTR2014-005012-42-LT
(EUCTR)
31/12/201528/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
123EUCTR2015-002698-39-DE
(EUCTR)
18/12/201530/09/2015A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 19.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
INN or Proposed INN: NA
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
INN or Proposed INN: NA
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
124EUCTR2014-005012-42-ES
(EUCTR)
18/12/201530/10/2015A Phase 3b clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cirrhosis.A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis 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: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Estonia;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;New Zealand;Sweden
125EUCTR2014-005012-42-BE
(EUCTR)
17/12/201529/09/2015 A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
428 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2014-005012-42-FI
(EUCTR)
14/12/201502/10/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against aplacebo, in conjunction with standard treatment, on selected clinicalmeasurements in patients with the liver disease, Primary BiliaryCholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, MulticenterStudy Evaluating the Effect of Obeticholic Acid on Clinical Outcomes inSubjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
127EUCTR2014-005012-42-AT
(EUCTR)
26/11/201528/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4Estonia;Serbia;Portugal;United States;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
128EUCTR2014-005012-42-DK
(EUCTR)
24/11/201529/09/2015 A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
428 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
129EUCTR2014-005012-42-GB
(EUCTR)
19/11/201509/10/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
130EUCTR2015-002698-39-GB
(EUCTR)
11/11/201517/09/2015A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). Primary Biliary Cirrhosis
MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MBX-8025
Product Code: MBX-8025
Other descriptive name: MBX-8025
Product Name: MBX 8025
Product Code: MBX 8025
Other descriptive name: MBX-8025
CymaBay Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Canada;Poland;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2014-005012-42-EE
(EUCTR)
09/11/201512/10/2015 A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with Obeticholic Acid in Liver Treatment (COBALT) A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with Obeticholic Acid in Liver Treatment (COBALT) 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]
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
428 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
132NCT02609048
(ClinicalTrials.gov)
November 201513/11/2015Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary Cirrhosis (PBC)Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mgCymaBay Therapeutics, Inc.NULLTerminated18 Years75 YearsAll41Phase 2United States;Canada;Germany;Poland;United Kingdom
133NCT02557360
(ClinicalTrials.gov)
November 201521/9/2015Effectiveness 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 UniversityCompletedN/AN/AAll24Phase 4Poland
134NCT02516605
(ClinicalTrials.gov)
September 9, 20154/8/2015A 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 PharmaceuticalsNULLCompleted18 YearsN/AAll61Phase 2United States;Canada;Germany;Poland;Russian Federation;United Kingdom
135EUCTR2014-001438-27-NL
(EUCTR)
19/08/201520/07/2015The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCH Primary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: BezalipAcademic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02321306
(ClinicalTrials.gov)
May 201512/12/2014An 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.NULLWithdrawn18 YearsN/AAll0Phase 2United States;United Kingdom
137NCT02193360
(ClinicalTrials.gov)
May 201511/7/2014Pilot 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 PharmaceuticalsNULLRecruiting18 Years75 YearsBoth24Phase 1/Phase 2Netherlands;United Kingdom
138EUCTR2014-001638-27-GB
(EUCTR)
16/02/201511/12/2014A dose finding study of FFP104 for patients with Primary Biliary Cirrhosis (PBC)A 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) - Pilot Study of FFP104 Dose Escalation in PBC Subjects Primary Biliary Cirrhosis (PBC)
MedDRA version: 19.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Fast Forward Pharmaceuticals, B.V.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands;United Kingdom
139NCT02360852
(ClinicalTrials.gov)
January 201514/1/2015IBAT 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, SwedenAlbireoTerminated18 Years80 YearsAll9Phase 2Sweden
140EUCTR2014-004070-42-SE
(EUCTR)
09/12/201415/10/2014Study to Demonstrate the Efficacy and Safety of A4250 in Patients withPrimary Biliary Cirrhosis and Cholestatic PruritusAn Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250 in Patients with Primary Biliary Cirrhosis andCholestatic Pruritus Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: A4250Sahlgrenska AcademyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02308111
(ClinicalTrials.gov)
December 201410/11/2014Phase 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 PharmaceuticalsNULLRecruiting18 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
142EUCTR2014-001638-27-NL
(EUCTR)
15/10/201421/07/2014A dose finding study of FFP104 for patients with Primary Biliary Cirrhosis (PBC)A 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) - Pilot Study of FFP104 Dose Escalation in PBC Subjects Primary Biliary Cirrhosis (PBC)
MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FFP104Fast Forward Pharmaceuticals, B.V.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Netherlands;United Kingdom
143NCT02078882
(ClinicalTrials.gov)
September 20143/3/2014Study 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 SquibbCompleted18 YearsN/AAll16Phase 4United States
144NCT02135536
(ClinicalTrials.gov)
May 20148/5/2014Phase 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 LtdCompleted18 Years75 YearsAll36Phase 2United States;Australia;New Zealand
145NCT01899703
(ClinicalTrials.gov)
March 10, 20143/7/2013A 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 acidGlaxoSmithKlineNULLCompleted18 Years75 YearsAll22Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146JPRN-UMIN000012782
2014/02/0101/02/2014Efficacy 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 UniversityNULLPendingNot applicableNot applicableMale and Female2Not selectedJapan
147NCT02026401
(ClinicalTrials.gov)
February 201430/12/2013Phase 2 Study of NGM282 in Patients With Primary Biliary CirrhosisA Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisBiological: NGM282;Biological: PlaceboNGM Biopharmaceuticals, IncNGM Biopharmaceuticals Australia Pty LtdCompleted18 Years75 YearsAll45Phase 2United States;Australia
148JPRN-UMIN000012489
2013/12/0404/12/2013Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis Osteoporosis 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 MedicineNULLComplete: follow-up continuing20years-oldNot applicableMale and Female20Not applicableJapan
149JPRN-UMIN000012193
2013/11/0101/11/2013Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis Osteoporosis 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 MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not applicableJapan
150NCT01865812
(ClinicalTrials.gov)
November 201323/5/2013Phase 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 PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01904058
(ClinicalTrials.gov)
August 201317/7/2013Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary CirrhosisA Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary CirrhosisPBC;Primary Biliary CirrhosisDrug: LUM001;Drug: Placebo;Drug: Ursodeoxycholic AcidMirum Pharmaceuticals, Inc.NULLCompleted18 Years80 YearsAll66Phase 2United States;Canada;United Kingdom
152EUCTR2013-000482-36-GB
(EUCTR)
08/07/201313/05/2013Phase 2 study to investigate use of LUM001 as a treatment for Primary Biliary Cirrhosis (PBC). This is a chronic and slowly progressive cholestatic liver disease of autoimmune aetiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure.A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifthto seventh decades of life at time of diagnosis, and 90% are women.
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: LUM001
INN or Proposed INN: LUM001
Lumena Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;United Kingdom
153NCT02963077
(ClinicalTrials.gov)
July 20131/11/2016A 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: PlaceboAlbireoNULLCompleted18 Years60 YearsBoth94Phase 1NULL
154NCT01879735
(ClinicalTrials.gov)
June 201311/6/2013Biliary 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 AarhusNULLCompleted18 YearsN/AAll22Phase 1Denmark
155EUCTR2007-004040-70-PL
(EUCTR)
30/04/201320/03/2013Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156JPRN-UMIN000015789
2012/11/3029/11/2015Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation non-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 CenterNULLRecruiting18years-old65years-oldMale and Female10Phase 1,2Japan
157NCT01654731
(ClinicalTrials.gov)
October 15, 201230/7/2012Phase 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 ParisNULLCompleted18 YearsN/AAll100Phase 3France
158NCT02376335
(ClinicalTrials.gov)
October 201224/2/2015B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary CirrhosisB-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary CirrhosisFatigue;Primary Biliary CirrhosisBiological: Rituximab;Other: PlaceboNewcastle-upon-Tyne Hospitals NHS TrustNational Institute for Health Research, United Kingdom;Department of Health, United Kingdom;Newcastle UniversityCompleted18 YearsN/AAll71Phase 2United Kingdom
159EUCTR2012-000145-12-GB
(EUCTR)
15/08/201204/07/2012Pilot study of Rituximab for the treatment of fatigue in PBCRituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC) - RITPBC Study Severe 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]
The Newcastle upon Tyne Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
58 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
160EUCTR2011-004728-36-NL
(EUCTR)
01/06/201215/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 18.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intercept Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT01614405
(ClinicalTrials.gov)
June 201225/4/2011Highly 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)Completed18 YearsN/ABoth13N/ACanada
162EUCTR2011-004728-36-PL
(EUCTR)
30/05/201220/04/2012A 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary 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)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Spain;Austria;Switzerland;United Kingdom;Italy;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
163EUCTR2011-004728-36-SE
(EUCTR)
16/04/201216/02/2012A 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary 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)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
164EUCTR2011-004728-36-BE
(EUCTR)
30/03/201213/02/2012A 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary 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)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
165EUCTR2011-004728-36-DE
(EUCTR)
22/03/201216/02/2012A 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary 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)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2011-004728-36-AT
(EUCTR)
13/03/201220/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary 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]
Intercept Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Belgium;Australia;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
167EUCTR2011-004728-36-IT
(EUCTR)
13/03/201205/03/2012A 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 Cirrhosis - A study of OCA in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 14.1;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
INTERCEPT PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
168EUCTR2011-004728-36-GB
(EUCTR)
09/03/201223/02/2012A 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
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]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
169EUCTR2011-004728-36-ES
(EUCTR)
22/02/201222/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 14.1;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intercept Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Germany;Netherlands;Sweden
170NCT01473524
(ClinicalTrials.gov)
January 201214/11/2011Phase 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 PharmaceuticalsNULLCompleted18 YearsN/AAll217Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT01430429
(ClinicalTrials.gov)
December 20115/9/2011Primary 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 SANULLTerminated18 YearsN/ABothPhase 2Italy;United Kingdom
172EUCTR2011-004681-15-AT
(EUCTR)
09/11/201119/10/2011Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosisEffects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezafibrat Genericon retard 400 mg
Product Name: Bezafibrat
Product Code: 1-20190
INN or Proposed INN: BEZAFIBRATE
Product Name: Ursodeoxycholsäure
Other descriptive name: URSODEOXYCHOLIC ACID
Medizinische Universität GrazNULLNot RecruitingFemale: yes
Male: yes
Austria
173NCT01440309
(ClinicalTrials.gov)
November 201120/9/2011Efficacy 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
174EUCTR2011-000554-31-SE
(EUCTR)
26/10/201116/08/2011A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI Primary Biliary Cirrhosis
MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2France;United States;Canada;Germany;Italy;United Kingdom;Sweden
175EUCTR2011-000554-31-GB
(EUCTR)
21/09/201112/07/2011A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI Primary Biliary Cirrhosis
MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2France;United States;Canada;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT01389973
(ClinicalTrials.gov)
September 20117/7/2011A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic AcidA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary CirrhosisDrug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll20Phase 2United States;Canada
177NCT01603199
(ClinicalTrials.gov)
September 201117/5/2012High-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 ZubiranNULLCompleted18 Years70 YearsBoth36N/AMexico
178EUCTR2011-001326-26-IT
(EUCTR)
21/06/201119/01/2012Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody.Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of increased ALP levels for at least 6 months - Positive serum AMA titer (>1:40) - Liver biopsy consistent with PBC Patient should be on incomplete response to UDCA
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NI-0801
Product Code: NI-0801
NOVIMMUNE BVNULLNot RecruitingFemale: yes
Male: yes
40Italy
179EUCTR2011-001326-26-GB
(EUCTR)
27/05/201124/03/2011Primary 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. - PIANO Primary 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
Other descriptive name: fully human monoclonal antibody directed against CXCL10
NovImmune S.A.NULLNot RecruitingFemale: yes
Male: yes
Italy;United Kingdom
180NCT01141296
(ClinicalTrials.gov)
April 20118/6/2010Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary CirrhosisRandomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: fenofibrate;Drug: placeboUniversity of MiamiMayo ClinicWithdrawn21 Years75 YearsBoth0Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT01249092
(ClinicalTrials.gov)
November 201024/11/2010Pentoxifylline for Primary Biliary CirrhosisA Pilot Study of Pentoxifylline for the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: PentoxifyllineThe Cleveland ClinicNULLCompleted18 Years76 YearsAll20Phase 2United States
182JPRN-UMIN000003802
2010/04/0122/06/2010Efficacy 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
183NCT01857284
(ClinicalTrials.gov)
September 200916/5/2013Safety 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 CompanyCompleted18 Years70 YearsBoth216Phase 3China
184EUCTR2007-004040-70-GB
(EUCTR)
01/06/200919/08/2008Double-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 PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
185NCT00943176
(ClinicalTrials.gov)
June 200917/7/2009Modafinil 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 GastroenterologyCompleted21 Years75 YearsBoth40Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2007-004040-70-IT
(EUCTR)
20/05/200922/05/2009Double-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 PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with PBC and with risk of a progression of this disease.
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budesonide
INN or Proposed INN: Budesonide
Trade Name: acido ursodessicolico
INN or Proposed INN: Ursodeoxycholic acid
DR. FALK PHARMA GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden
187EUCTR2007-001424-12-DE
(EUCTR)
22/04/200923/10/2008A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Spain;Austria;Germany;United Kingdom
188EUCTR2007-001424-12-GB
(EUCTR)
21/04/200903/09/2007 A Study of INT 747 Monotherapy in Patients with Primary Biliary Cirrhosis A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis 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]
Intercept PharmaceuticalsNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Germany;United Kingdom
189EUCTR2007-004040-70-AT
(EUCTR)
19/03/200923/06/2008Double-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 PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
190EUCTR2007-001425-10-AT
(EUCTR)
13/03/200927/08/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2007-001424-12-AT
(EUCTR)
13/03/200909/09/2008A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Spain;Austria;Germany;United Kingdom
192EUCTR2007-001425-10-NL
(EUCTR)
11/02/200903/09/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
193NCT00746486
(ClinicalTrials.gov)
February 20093/9/2008Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)Double-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 CirrhosisPrimary Biliary CirrhosisDrug: budesonide;Drug: budesonide placeboDr. Falk Pharma GmbHNULLTerminated18 YearsN/AAll62Phase 3France;Germany
194EUCTR2007-004040-70-DK
(EUCTR)
29/01/200919/11/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
195EUCTR2007-001425-10-DE
(EUCTR)
27/01/200924/10/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140United Kingdom;Germany;Netherlands;France;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2007-004040-70-LT
(EUCTR)
22/12/200816/09/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
197EUCTR2008-001524-31-NL
(EUCTR)
26/11/200817/07/2008Double-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 PBC Treatment of primary biliary cirrhosis
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® capsules
INN or Proposed INN: URSODEOXYCHOLIC ACID
Trade Name: Ursofalk® 500 mg film-coated tablets
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 4Germany;Netherlands
198EUCTR2007-004040-70-FI
(EUCTR)
10/11/200825/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
199NCT01510860
(ClinicalTrials.gov)
November 200812/1/2012Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary CirrhosisDouble-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: UDCA (Ursodeoxycholic acid)Dr. Falk Pharma GmbHNULLCompleted18 YearsN/AAll65Phase 4Germany
200EUCTR2007-004040-70-HU
(EUCTR)
18/10/200804/08/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2007-001425-10-GB
(EUCTR)
13/10/200827/06/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
202EUCTR2007-004040-70-ES
(EUCTR)
01/10/200801/08/2008Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-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 PBCEstudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
203EUCTR2007-001425-10-FR
(EUCTR)
26/09/200806/08/2008A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
204EUCTR2007-001425-10-ES
(EUCTR)
24/09/200823/07/2008Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary CirrhosisEstudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis cirrosis biliar primaria
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Germany;United Kingdom;Netherlands;France;Spain;Austria
205EUCTR2007-004040-70-SE
(EUCTR)
22/09/200802/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2007-004040-70-FR
(EUCTR)
09/09/200809/06/2008Double-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 PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden
207EUCTR2008-001524-31-DE
(EUCTR)
26/08/200811/07/2008Double-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 PBC Treatment of primary biliary cirrhosis
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® capsules
INN or Proposed INN: URSODEOXYCHOLIC ACID
Trade Name: Ursofalk® 500 mg film-coated tablets
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
74Phase 4Germany;Netherlands
208EUCTR2007-004040-70-NL
(EUCTR)
11/08/200823/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
209EUCTR2007-001424-12-FR
(EUCTR)
29/07/200816/05/2008A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Spain;Austria;Germany;United Kingdom
210EUCTR2007-001424-12-ES
(EUCTR)
15/07/200822/05/2008Estudio de la monoterapia INT-747 (6-ECDCA) en pacientes concirrosis biliar primariaA Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis Estudio de la monoterapia INT-747 (6-ECDCA) en pacientes concirrosis biliar primariaA Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis cirrosis biliar primaria
MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
Intercept PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Spain;Austria;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2007-004040-70-DE
(EUCTR)
15/05/200814/03/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
212EUCTR2006-006742-34-GB
(EUCTR)
20/12/200703/06/2007The 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
Barts and The London NHS TrustNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
213NCT00587119
(ClinicalTrials.gov)
December 200721/12/2007Oral 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 ClinicNULLWithdrawn21 Years75 YearsBoth0N/AUnited States
214NCT00570765
(ClinicalTrials.gov)
November 20077/12/2007Study 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 PharmaceuticalsNULLCompleted18 Years70 YearsAll59Phase 2United States;Austria;Canada;France;Germany;Spain;United Kingdom
215NCT00550862
(ClinicalTrials.gov)
October 200727/10/2007Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)A Study of INT 747 (6a-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: INT-747;Drug: Ursodeoxycholic Acid (URSO);Drug: PlaceboIntercept PharmaceuticalsNULLCompleted18 Years70 YearsAll165Phase 2United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT00575042
(ClinicalTrials.gov)
August 200713/12/2007Use of Fenofibrate for Primary Biliary CirrhosisPilot Study of Fenofibrate for Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)University of FloridaThe PBCers Organization;Shionogi Inc.Completed21 Years75 YearsAll20Phase 2United States
217NCT00364819
(ClinicalTrials.gov)
January 200715/8/2006Initial 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.Completed18 Years65 YearsFemale6Phase 1/Phase 2United States
218NCT00406237
(ClinicalTrials.gov)
December 200629/11/2006Pharmacokinetic 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 PfizerNULLCompleted18 YearsN/ABoth8Phase 1United States;Puerto Rico
219EUCTR2006-003712-22-DE
(EUCTR)
23/10/200618/09/2006Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteersPharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers Primary Biliary Cirrhosis Stage I-III
MedDRA version: 12.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® 500 mg Filmtabletten
Product Name: Ursofalk® 500 mg Filmtabletten
INN or Proposed INN: Ursodeoxycholic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
24Germany
220NCT00805805
(ClinicalTrials.gov)
April 20068/12/2008Study 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 DevelopmentCompleted18 YearsN/AAll29Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT00844402
(ClinicalTrials.gov)
January 200613/2/2009Safety 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 GrazNULLCompleted18 Years70 YearsBoth40Phase 3Austria
222NCT00393185
(ClinicalTrials.gov)
January 200624/10/2006Stem 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 HospitalWithdrawn18 Years55 YearsBoth0Phase 1United States
223EUCTR2005-002160-28-AT
(EUCTR)
23/09/200519/08/2005Safety 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 cirrhosis Reduction 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
INN or Proposed INN: Atorvastatin
Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and HepatologyNULLNot RecruitingFemale: yes
Male: yes
80Austria
224NCT00125281
(ClinicalTrials.gov)
July 25, 200529/7/2005SAMe 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)NULLTerminated21 YearsN/AAll50Phase 2United States
225NCT00490620
(ClinicalTrials.gov)
January 200421/6/2007Study 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 PharmaCompleted18 Years75 YearsBoth59Phase 2/Phase 3United States;Canada;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226JPRN-C000000225
2003/12/0113/09/2008Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis Primary biliary cirrhosisIntervention:UDCA+Bezafibrate
Bezafibrate: 400mg/day for 12 months
Dose of pretreatment UDCA is not changed after entry.
control:UDCA only
Dose of pretreatment UDCA is not changed after entry.
Gunma Liver Study GroupNULLComplete: follow-up complete20years-old85years-oldMale and Female20Not applicableJapan
227NCT00588302
(ClinicalTrials.gov)
June 200322/12/2007Moexipril for Primary Biliary CirrhosisOpen-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC)Primary Biliary CirrhosisDrug: MoexiprilMayo ClinicUCB PharmaCompleted18 Years85 YearsBoth20Phase 2United States
228NCT00004784
(ClinicalTrials.gov)
January 199424/2/2000Phase 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 TexasCompleted20 Years69 YearsBoth315Phase 3NULL
229NCT00006168
(ClinicalTrials.gov)
January 19948/8/2000Ursodiol-Methotrexate for Primary Biliary CirrhosisLiver Cirrhosis, BiliaryDrug: MethotrexateNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted20 Years69 YearsBothPhase 3United States
230NCT00004748
(ClinicalTrials.gov)
November 198924/2/2000Low-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 CenterCompletedN/AN/ABoth90Phase 3NULL