| 1 |
NCT02937012 |
Recruiting |
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders |
- Primary Biliary Cirrhosis
|
- Drug: Bezafibrate
- Drug: Ursodeoxycholic Acid
- Drug: Placebo (for Bezafibrate)
|
Interventional |
Phase 3 |
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Complete biochemical response
- Increase in liver transaminases or development of rhabdomyolysis
|
34 |
All |
18 Years to 65 Years (Adult) |
NCT02937012 |
1757 |
|
October 2016 |
April 2018 |
April 2018 |
October 18, 2016 |
October 18, 2016 |
|
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico
|
| 2 |
NCT01161953 |
Recruiting |
Genetic Epidemiology of Primary Biliary Cirrhosis (PBC) |
- Primary Biliary Cirrhosis
|
- Genetic: Genetic Analysis
|
Observational |
|
|
Other |
- Observational Model: Family-Based
- Time Perspective: Other
|
- Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases
|
1500 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01161953 |
670-02 PBC |
|
March 2002 |
December 2025 |
December 2025 |
July 14, 2010 |
August 22, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 3 |
NCT02823353 |
Recruiting |
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis |
- Primary Biliary Cirrhosis
|
- Drug: Fenofibrate
- Drug: UDCA
|
Interventional |
Phase 3 |
- Xijing Hospital of Digestive Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with complete biochemical response
- Change in liver biopsy examinations according to conventional Ludwig system.
- GLOBE risk scores at week 48.
- (and 4 more...)
|
200 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02823353 |
KY20151230-4 |
|
January 2016 |
July 2018 |
July 2018 |
July 6, 2016 |
July 7, 2016 |
|
- Xijing Hosipital
Xi`an, Shaanxi, China
|
| 4 |
NCT03476993 |
Not yet recruiting
New |
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of patients with alkaline phosphatase (ALP) decrease > 40% from Baseline (day 1 week 0) or with normal ALP level (Barcelona criteria) after 24 weeks of treatment with BCD-085 in combination with UDCA.
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT03476993 |
BCD-085-6 |
|
April 2018 |
April 2020 |
December 2021 |
March 26, 2018 |
March 26, 2018 |
|
- State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
|
| 5 |
NCT03146910 |
Recruiting |
Swiss Primary Biliary Cholangitis Cohort Study |
|
|
Observational |
|
- Fondazione Epatocentro Ticino
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease course
- Disease features
- Response to treatment
- (and 2 more...)
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT03146910 |
SASL39 - Swiss PBC Cohort |
|
February 15, 2017 |
December 31, 2022 |
December 31, 2022 |
May 10, 2017 |
May 10, 2017 |
|
- Fondazione Epatocentro Ticino
Lugano, Ticino, Switzerland - Inselspital
Bern, Switzerland - Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
Geneve, Switzerland - (and 3 more...)
|
| 6 |
NCT02308111 |
Recruiting |
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis |
|
- Drug: Obeticholic Acid (OCA)
- Drug: Placebo
|
Interventional |
Phase 4 |
- Intercept Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Composite endpoint of any of the five listed adjudicated events
- First occurrence of each of the listed individual events
- First occurrence of liver-related death
- (and 14 more...)
|
428 |
All |
18 Years and older (Adult, Senior) |
NCT02308111 |
747-302 |
COBALT |
December 2014 |
December 2024 |
April 2025 |
December 4, 2014 |
March 13, 2018 |
|
- Mayo Clinic
Phoenix, Arizona, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Inland Empire Liver Foundation
Rialto, California, United States - (and 156 more...)
|
| 7 |
NCT03468699 |
Recruiting |
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia |
|
- Combination Product: Autologous BMMC transplantation
|
Interventional |
Phase 2 |
- Vinmec Research Institute of Stem Cell and Gene Technology
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess the changes in cholestasis
- Assess the changes in Liver function
- Assess the changes in level of cirrhosis
- Assess the changes in liver biopsy
|
20 |
All |
1 Year to 15 Years (Child) |
NCT03468699 |
VinmecRISCGT78 |
|
January 2, 2017 |
December 31, 2018 |
December 31, 2018 |
March 16, 2018 |
March 16, 2018 |
|
- Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam - Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam
|
| 8 |
NCT02916290 |
Recruiting |
Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis |
- Primary Biliary Cirrhosis
|
- Drug: Fuzhenghuayu
- Drug: UDCA
|
Interventional |
Phase 3 |
- Xijing Hospital of Digestive Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with complete biochemical response
- Change in liver biopsy examinations compared to the baseline.
- GLOBE scores.
- (and 4 more...)
|
200 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02916290 |
KY20151230-6 |
|
January 2016 |
December 2018 |
|
September 27, 2016 |
September 27, 2016 |
|
- Xijing Hosipital of Digestive Disease
Xi`an, Shaanxi, China
|
| 9 |
NCT02823366 |
Recruiting |
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid |
- Primary Biliary Cirrhosis
|
- Drug: Fenofibrate
- Drug: UDCA
|
Interventional |
Phase 3 |
- Xijing Hospital of Digestive Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with complete biochemical response
- Change in liver biopsy examinations according to conventional Ludwig system.
- Change in GLOBE risk scores after treatment.
- (and 4 more...)
|
200 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02823366 |
KY20151230-5 |
|
January 2016 |
June 2017 |
|
July 6, 2016 |
July 7, 2016 |
|
- Xijing Hosipital
Xi`an, Shaanxi, China
|
| 10 |
NCT02193360 |
Recruiting |
Pilot Study of FFP104 Dose Escalation in PBC Subjects |
- Primary Biliary Cirrhosis
|
|
Interventional |
Phase 1
Phase 2 |
- Fast Forward Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of FFP104 in PBC subjects following repeat doses of FFP104
- Proportion of subjects with a 10% decrease in Alkaline Phosphatase (ALP) from baseline values
- Proportion of subjects with a 25 and 40% decrease in ALP from baseline
- (and 8 more...)
|
24 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02193360 |
FFP104-001
2014-001638-27 |
|
May 2015 |
August 2017 |
December 2017 |
July 17, 2014 |
August 24, 2016 |
|
- Amsterdam Medical Center
Amsterdam, Netherlands - Erasmus University Medical Center
Rotterdam, Netherlands - University Hospital Birmingham
Birmingham, United Kingdom - (and 2 more...)
|
| 11 |
NCT03253276 |
Recruiting |
Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT |
- Primary Biliary Cirrhosis
|
- Drug: Obeticholic acid
- Drug: Placebos
|
Interventional |
Early Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Effect of OCA on bile flow
|
8 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03253276 |
OCAPBC |
|
May 19, 2016 |
January 20, 2018 |
March 31, 2018 |
August 17, 2017 |
August 22, 2017 |
|
- Susanne Keiding
Aarhus, Denmark
|
| 12 |
NCT02965911 |
Recruiting |
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA |
- Primary Biliary Cirrhosis
|
- Drug: Fenofibrate
- Drug: UDCA
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum Level of Alkaline Phosphatase(ALP) value
- Total bilirubin(TBIL) value
- Aspartate aminotransferase(AST) value
- Serum Level of Gamma-glutamyl transpeptidase (GGT) value
|
72 |
All |
18 Years to 65 Years (Adult) |
NCT02965911 |
BJ302-FGRXGB-002 |
|
January 2016 |
January 2019 |
January 2019 |
November 17, 2016 |
November 17, 2016 |
|
- Beijing 302 hospital
Beijing, China
|
| 13 |
NCT02916641 |
Recruiting |
Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid |
- Primary Biliary Cirrhosis
|
- Drug: Fuzhenghuayu
- Drug: UDCA
|
Interventional |
Phase 3 |
- Xijing Hospital of Digestive Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with complete biochemical response
- Change in liver biopsy examinations compared to the baseline.
- Change in GLOBE scores after treatment.
- (and 4 more...)
|
200 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02916641 |
KY20151230-7 |
|
January 2016 |
December 2018 |
|
September 27, 2016 |
September 27, 2016 |
|
- Xijing Hosipital of Digestive Disease
Xi`an, Shaanxi, China
|
| 14 |
NCT02477462 |
Recruiting |
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients |
- Primary Biliary Cirrhosis
|
- Other: Clinic visit
- Other: Baseline visit
|
Observational |
|
- University of California, Davis
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Phenotypic Analysis
- Liver Imaging Analysis
- Phlebotomy Injuries
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02477462 |
703097 |
|
May 2015 |
May 2019 |
May 2019 |
June 22, 2015 |
March 1, 2018 |
|
- University of California Davis Medical Center
Sacramento, California, United States
|
| 15 |
NCT03489889 |
Recruiting
New |
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine |
- Ursodeoxycholic Acid
- Primary Biliary Cirrhosis
|
- Drug: Ursodeoxycholic Acid 300mg tablet
- Drug: Ursodeoxycholic Acid 300mg capsule
|
Interventional |
Not Applicable |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Therapeutic efficacy between capsule and tablet
|
28 |
All |
18 Years and older (Adult, Senior) |
NCT03489889 |
Gastro FMUSP |
|
December 2016 |
December 2017 |
June 2018 |
April 6, 2018 |
April 10, 2018 |
|
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
|
| 16 |
NCT03301506 |
Recruiting |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) |
- Primary Biliary Cirrhosis
|
- Drug: Seladelpar 2 mg Capsule
- Drug: Seladelpar 5 mg Capsule
- Drug: Seladelpar 10 mg Capsule
|
Interventional |
Phase 2
Phase 3 |
- CymaBay Therapeutics, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events (AE) and Treatment Emergent Adverse Events (TEAEs), Biochemistry and Hematology and NCI CTCAE Version 4.0
- Laboratory Value: Serum Alkaline Phosphatase (AP)
- Laboratory Value: Aspartate Aminotransferase (AST)
- (and 11 more...)
|
356 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03301506 |
CB8025-31731 |
|
December 12, 2017 |
December 2020 |
March 2022 |
October 4, 2017 |
April 5, 2018 |
|
- Southern California Liver & GI Center
Coronado, California, United States - University of California, Davis Medical Center
Sacramento, California, United States - Digestive Healthcare of Georgia
Atlanta, Georgia, United States - (and 13 more...)
|
| 17 |
NCT03226067 |
Recruiting |
Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. |
- Primary Biliary Cirrhosis
|
- Drug: GKT137831
- Drug: Placebo oral capsule
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The percent change in serum GGT.
- Absolute change in serum GGT
- Percent change in serum GGT
- (and 25 more...)
|
102 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03226067 |
GSN000300
2016-004599-23 |
|
June 26, 2017 |
August 20, 2018 |
August 20, 2018 |
July 21, 2017 |
March 12, 2018 |
|
- Mayo Clinic
Phoenix, Arizona, United States - University California Davis
Sacramento, California, United States - Ventura Clinical Trials
Ventura, California, United States - (and 53 more...)
|
| 18 |
NCT03112681 |
Recruiting |
A Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS) |
- Primary Biliary Cirrhosis
|
- Drug: Saroglitazar magnesium 2 mg
- Drug: Saroglitazar magnesium 4 mg
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis.
|
36 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03112681 |
SARO.16.004.03.PROT |
EPICS |
August 18, 2017 |
January 2019 |
March 2019 |
April 13, 2017 |
April 2, 2018 |
|
- Indiana University School of Medicine
Indianapolis, Indiana, United States - Rutgers NJ Medical School
Newark, New Jersey, United States - Sandra Atlas Bass Center for Liver Diseases- Northwell Health
Manhasset, New York, United States - (and 7 more...)
|
| 19 |
NCT02955602 |
Recruiting |
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) |
- Primary Biliary Cirrhosis
|
- Drug: MBX-8025 2 mg Capsule
- Drug: MBX-8025 5 mg Capsule
- Drug: MBX-8025 10 mg Capsule
|
Interventional |
Phase 2 |
- CymaBay Therapeutics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum Alkaline Phosphatase (AP)
- Adverse events (AE) and Treatment Emergent Adverse Events (TEAEs), ECG, biochemistry, hematology and urinalysis (NCI CTCAE Version 4.0)
- Aspartate Aminotransferase (AST)
- (and 22 more...)
|
116 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02955602 |
CB8025-21629 |
|
November 28, 2016 |
July 2019 |
January 2020 |
November 4, 2016 |
February 26, 2018 |
|
- Southern California Research Center
Coronado, California, United States - Standford University Medicine
Palo Alto, California, United States - University of California, Davis Medical Center
Sacramento, California, United States - (and 33 more...)
|
| 20 |
NCT02932449 |
Recruiting |
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis |
- Biliary Cirrhosis, Primary
|
|
Observational |
|
- Target PharmaSolutions, Inc.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Other
|
- Evaluate PBC treatment regimens being used in clinical practice
- Examine populations underrepresented in phase III clinical trials
- Examine biochemical response and its association with long term outcomes
- Estimate adverse event frequency and severity and describe management practices
|
1500 |
All |
18 Years and older (Adult, Senior) |
NCT02932449 |
TARGET-PBC |
|
October 2016 |
September 2021 |
September 2021 |
October 13, 2016 |
April 13, 2018 |
|
- Banner University Medical Center
Phoenix, Arizona, United States - Mayo Clinic
Phoenix, Arizona, United States - University of Arkansas
Little Rock, Arkansas, United States - (and 24 more...)
|
| 21 |
NCT02924701 |
Recruiting |
sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis |
- Primary Biliary Cirrhosis
- Liver Inflammation
|
- Other: Blood samples, fibroscan and questionaires
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease progression (Blood samples)
- All-cause mortality (Information from medical journal)
- Liver stiffness (fibroscan)
- (and 2 more...)
|
140 |
All |
18 Years and older (Adult, Senior) |
NCT02924701 |
PBC AU 1 |
|
September 2016 |
June 2021 |
June 2021 |
October 5, 2016 |
November 1, 2016 |
|
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark
Aarhus C, Region midtjylland, Denmark
|
| 22 |
NCT02931513 |
Recruiting |
sCD163 in PBC Patients - Assessment of Treatment Response |
- Primary Biliary Cirrhosis
- Liver Inflammation
- Ursodeoxycholic Acid
|
- Other: Blood samples
- Device: Fibroscan
- Other: Questionnaires
- Biological: Liver biopsy
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- UDCA response (ALP <3 times upper normal limit, AST <2 times upper normal limit, and bilirubin ≤1 mg/dL after one year of treatment)
- disease progression (blood samples, fibroscan, questionnaires)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02931513 |
PBC AU 2 |
|
September 2016 |
June 2021 |
June 2021 |
October 13, 2016 |
November 1, 2016 |
|
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark
Aarhus C, Region midtjylland, Denmark
|
| 23 |
NCT03337074 |
Recruiting |
Paternally Inherited Phenotypes in Cholestasis |
- Cholestasis
- Primary Sclerosing Cholangitis
- Primary Biliary Cirrhosis
|
- Other: Questionnaire, semen sample, fasting blood sample
- Other: Questionnaire
- Other: Questionnaire, fasting blood sample
|
Observational |
|
- Guy's and St Thomas' NHS Foundation Trust
- King's College Hospital NHS Trust
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Impact of male cholestasis on DNA methylation patterns in sperm
- Impact of male cholestasis on small RNA content in sperm
- Impact of male cholestasis on sperm histone retention
- (and 3 more...)
|
200 |
All |
16 Years and older (Child, Adult, Senior) |
NCT03337074 |
182833 |
PIP-C |
February 8, 2017 |
April 1, 2018 |
April 3, 2020 |
November 8, 2017 |
March 29, 2018 |
|
- Assisted Conception Unit, Guy's Hospital
London, United Kingdom - King's College Hospital
London, United Kingdom
|
| 24 |
NCT02516605 |
Recruiting |
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients |
- Primary Biliary Cholangitis
|
- Drug: Part 1: LJN452
- Drug: Part 1: Placebo
- Drug: Part 2: LJN452 Dose level 1
- (and 2 more...)
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in cholestatic markers from baseline
- Number of patients with adverse events, serious adverse events and death
- Change from baseline in disease specific quality of life
- (and 7 more...)
|
163 |
All |
18 Years and older (Adult, Senior) |
NCT02516605 |
CLJN452X2201
2015-001590-41 |
|
September 9, 2015 |
December 10, 2019 |
December 10, 2019 |
August 6, 2015 |
April 19, 2018 |
|
- Novartis Investigative Site
Rialto, California, United States - Novartis Investigative Site
Bradenton, Florida, United States - Novartis Investigative Site
Miami, Florida, United States - (and 26 more...)
|
| 25 |
NCT02936596 |
Recruiting |
Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome |
- Hepatitis, Autoimmune
- Cholangitis
- Liver Cirrhosis, Biliary
- Cholestasis
|
- Drug: Ursodeoxycholic acid combination of immunosuppressive agents
- Drug: Ursodeoxycholic Acid
|
Interventional |
Not Applicable |
- Xiaoli Fan
- West China Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
- Alanine transaminase (ALT)
- Aspartate transaminase(AST)
- (and 7 more...)
|
53 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02936596 |
OS-1 |
|
December 2016 |
August 2017 |
|
October 18, 2016 |
December 12, 2016 |
|
- West China Hospital
Chengdu, Sichuan, China
|
| 26 |
NCT03394924 |
Recruiting |
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
- Drug: EDP-305 Dose 1
- Drug: EDP-305 Dose 2
- Drug: Placebo
|
Interventional |
Phase 2 |
- Enanta Pharmaceuticals
- Pharmaceutical Research Associates
- Triangle Biostatistics
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12
- Safety as measured by • Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12
- Change from baseline in Bilirubin
- (and 20 more...)
|
119 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03394924 |
EDP 305-201 |
|
December 27, 2017 |
March 2019 |
April 2019 |
January 9, 2018 |
March 21, 2018 |
|
- Inland Empire Liver Foundation
Rialto, California, United States - American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
|
| 27 |
NCT03345589 |
Not yet recruiting |
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
- Drug: 18-22mg/kg/d Ursodeoxycholic
- Drug: 13-15mg/kg/d Ursodeoxycholic
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
- Alkaline phosphatase
- Glutamyltransferase
- (and 3 more...)
|
40 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03345589 |
PBC-3 |
|
January 30, 2018 |
December 1, 2018 |
January 1, 2019 |
November 17, 2017 |
January 9, 2018 |
|
|
| 28 |
NCT03322943 |
Recruiting |
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital |
- Primary Biliary Cholangitis
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Description of demographics, clinical index after treatment
- Evaluation whether the PBC patients have response after treatment
|
300 |
All |
25 Years to 85 Years (Adult, Senior) |
NCT03322943 |
PBC-2 |
|
January 1, 2016 |
September 1, 2018 |
December 1, 2018 |
October 26, 2017 |
October 26, 2017 |
|
- West China Hospital
Chengdu, Sichuan, China
|
| 29 |
NCT03188146 |
Recruiting |
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid |
- Primary Biliary Cholangitis (PBC)
|
- Drug: Ursodeoxycholic Acid
|
Observational |
|
- Humanity and Health Research Centre
- Beijing 302 Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Liver related Death
- Complications of cirrhosis
- Liver transplant
|
500 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03188146 |
H&H_PBC_01 |
|
May 1, 2017 |
May 1, 2027 |
May 1, 2028 |
June 15, 2017 |
June 15, 2017 |
|
- Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.
Beijing, China
|
| 30 |
NCT03155932 |
Recruiting |
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline to Week 24 in serum ALP concentration.
- Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis).
- Change from baseline to Week 12 in serum ALP concentration.
- (and 14 more...)
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03155932 |
APD334-010 |
|
December 15, 2017 |
December 2018 |
December 2018 |
May 16, 2017 |
April 19, 2018 |
|
- Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia - Sunshine Coast University Hospital
Birtinya, Queensland, Australia - Alfred Health
Melbourne, Victoria, Australia - (and 2 more...)
|
| 31 |
NCT03124108 |
Recruiting |
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid |
- Primary Biliary Cholangitis (PBC)
|
- Drug: Elafibranor 80 mg
- Drug: Elafibranor 120 mg
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in serum alkaline phosphatase (ALP)
- Composite endpoint composed of ALP and total bilirubin
- Paris I PBC risk score
- (and 12 more...)
|
45 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03124108 |
GFT505B-216-1
2016-003817-80 |
|
April 5, 2017 |
April 2018 |
April 2018 |
April 21, 2017 |
February 21, 2018 |
|
- Mayo Clinic in Arizona
Phoenix, Arizona, United States - Schiff Center for Liver Diseases
Miami, Florida, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - (and 17 more...)
|
| 32 |
NCT03092765 |
Recruiting |
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid |
- Primary Biliary Cholangitis
|
|
Interventional |
Phase 2 |
- EA Pharma Co., Ltd.
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
- Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
- Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
- (and 24 more...)
|
80 |
All |
20 Years to 74 Years (Adult, Senior) |
NCT03092765 |
E6011/ET1 |
|
March 23, 2017 |
February 2020 |
March 2020 |
March 28, 2017 |
October 24, 2017 |
|
- EA Pharma trial site
Toon, Ehime, Japan - EA Pharma trial site
Yoshida, Fukui, Japan - EA Pharma trial site #1
Fukuoka-shi, Fukuoka, Japan - (and 17 more...)
|
| 33 |
NCT02943447 |
Recruiting |
Safety, Tolerability, and Efficacy of GS 9674 in Adults With Primary Biliary Cholangitis Without Cirrhosis |
- Primary Biliary Cholangitis
|
- Drug: GS-9674
- Drug: Placebo to match GS-9674
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events
- Incidence of Treatment-Emergent Serious Adverse Events
- Incidence of treatment-emergent laboratory abnormalities
|
75 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02943447 |
GS-US-427-4024
2016-002443-42 |
PBC-Phase 2 |
December 1, 2016 |
July 2018 |
February 2020 |
October 24, 2016 |
March 14, 2018 |
|
- Phoenix, Arizona, United States
- Fresno, California, United States
- Sacramento, California, United States
- (and 33 more...)
|
| 34 |
NCT00001971 |
Recruiting |
Evaluation of Patients With Liver Disease |
- Biliary Liver Cirrhosis
- Hemochromatosis
- Hepatitis
- (and 2 more...)
|
|
Observational |
|
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
99999999 |
All |
2 Years and older (Child, Adult, Senior) |
NCT00001971 |
910214
91-DK-0214 |
|
September 10, 1991 |
|
|
January 19, 2000 |
April 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 35 |
NCT03265249 |
Not yet recruiting |
BRIDGE Device for Post-operative Pain Control |
- Liver Failure
- Liver Diseases, Alcoholic
- Liver Diseases
- (and 3 more...)
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- opioid usage after surgery as measured by based on daily number of doses and total morphine equivalents used at different time points during the post-operative course.
- Pain level
- reduction in nausea scores as measured by a 4-item questionnaire response
- (and 5 more...)
|
50 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03265249 |
Pro00084620 |
BRIDGE |
February 15, 2018 |
October 1, 2018 |
October 1, 2018 |
August 29, 2017 |
February 1, 2018 |
|
|
| 36 |
NCT02966834 |
Recruiting |
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis |
|
- Drug: Placebo
- Drug: GSK2330672
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean change from Baseline at Week 16 in the Mean Worst Daily Itch Score
- Mean change from Baseline at Week 16 in PBC-40 scale
- Mean change from Baseline at Week 16 in serum alkaline phosphatase (ALP) concentrations, in participants with high risk of PBC progression
- (and 26 more...)
|
118 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02966834 |
201000 |
|
January 11, 2017 |
August 9, 2019 |
August 9, 2019 |
November 17, 2016 |
April 10, 2018 |
|
- GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Sacramento, California, United States - GSK Investigational Site
Miami, Florida, United States - (and 63 more...)
|
| 37 |
NCT01200082 |
Recruiting |
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Urinary bile acid indexes
- mayo model for end-stage liver disease score (MELD)
|
400 |
All |
19 Years to 65 Years (Adult) |
NCT01200082 |
487-10-EP |
|
November 2011 |
December 31, 2020 |
December 31, 2020 |
September 13, 2010 |
September 11, 2017 |
|
- University of Nebraska Medial Center
Omaha, Nebraska, United States
|
| 38 |
NCT01931644 |
Recruiting |
Be the Bridge Between Researchers and a Cure (GVHD, ALS, Hepatitis B, Alzheimer's Disease, Leukemia, and More) |
- All Diagnosed Health Conditions
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Biospecimen & Clinical Data Collection
|
20000 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT01931644 |
SAN-BB-01 |
|
July 2013 |
August 2020 |
December 2040 |
August 29, 2013 |
April 18, 2018 |
|
- Sanguine Biosciences
Los Angeles, California, United States
|
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