Clinical trials: Biliary Cirrhosis, Primary
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Primary Sclerosing Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT02943460
- Testing
- Cilofexor
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2.
- Trial name
- NCT06371196
- Testing
- Babaodan Capsule
- Volunteers
- 60 people
- Sponsor
- Mei Han
Primary Biliary Cholangitis (PBC)
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT07104201
- Testing
- Fenofibrate
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
PBC
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression
Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver…
- Trial name
- NCT07733882
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Primary Biliary Cirrhosis
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to several symptoms such as intractable pruritus or chronic fatigue, significantly impairing patients quality of life.
- Trial name
- NCT02557360
- Testing
- S-adenosyl-L-methionine
- Where
- 2 sites in Poland
- Volunteers
- 24 people
- Sponsor
- Pomeranian Medical University Szczecin
Primary Biliary Cirrhosis
Pentoxifylline for Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.
- Trial name
- NCT01249092
- Testing
- Pentoxifylline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Primary Biliary Cirrhosis
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
- Trial name
- NCT01857284
- Testing
- Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules
- Where
- 25 sites in China
- Volunteers
- 216 people
- Sponsor
- Beijing Friendship Hospital
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Trial name
- NCT03345589
- Testing
- 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic
- Where
- China
- Volunteers
- 40 people
- Sponsor
- West China Hospital
Primary Biliary Cirrhosis
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol…
- Trial name
- PBC (NCT02078882)
- Testing
- abatacept
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Christopher Bowlus, MD
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
- Trial name
- NCT04047160
- Testing
- OP-724
- Where
- 2 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Kiminori Kimura, MD
Primary Biliary Cholangitis
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
- Trial name
- NCT06888115
- Testing
- CS0159
- Where
- 3 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Primary Biliary Cirrhosis
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.
- Trial name
- NCT00746486
- Testing
- budesonide
- Where
- 2 sites in France, Germany
- Volunteers
- 62 people
- Sponsor
- Dr. Falk Pharma GmbH
Cholangitis, Liver Cirrhosis, Biliary
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.
- Conditions
- Cholangitis, Liver Cirrhosis, Biliary, Cholestasis, Liver Diseases
- Trial name
- NCT02917408
- Where
- China
- Volunteers
- 769 people
- Sponsor
- Xiaoli Fan
Primary Biliary Cholangitis
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid…
- Trial name
- HEROES-PBC (NCT05293938)
- Testing
- Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA
- Where
- United States
- Sponsor
- Intercept Pharmaceuticals