Clinical trials: Primary Biliary Cholangitis
Primary Biliary Cholangitis
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT03155932
- Testing
- APD334
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 2 people
- Sponsor
- Arena Pharmaceuticals
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Use of Fenofibrate for Primary Biliary Cirrhosis
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
- Trial name
- NCT00575042
- Testing
- Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Primary Sclerosing Cholangitis
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
- Trial name
- PRIMIS (NCT03890120)
- Testing
- Cilofexor
- Where
- 201 sites in United States, Australia and 14 more
- Volunteers
- 419 people
- Sponsor
- Gilead Sciences
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Liver Cirrhosis, Biliary
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
- Trial name
- NCT00570765
- Testing
- Obeticholic Acid (OCA)
- Where
- 21 sites in United States, Austria and 5 more
- Volunteers
- 60 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis (PBC)
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT02609048
- Testing
- Experimental: Seladelpar 50 mg, Experimental: Seladelpar / MBX-8025 200 mg
- Where
- 49 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Liver Cirrhosis, Biliary
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver…
- Trial name
- COBALT (NCT02308111)
- Testing
- Obeticholic Acid (OCA)
- Where
- 181 sites in United States, Argentina and 29 more
- Volunteers
- 334 people
- Sponsor
- Intercept Pharmaceuticals
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 Sclerosing Cholangitis
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
- Trial name
- PSC (NCT01085760)
- Testing
- Vancomycin, Metronidazole
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis
Seladelpar (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…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
- Trial name
- PSC (NCT01802073)
- Testing
- Oral Vancomycin
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Stanford University
Primary Biliary Cirrhosis
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high…
- Trial name
- NCT03226067
- Testing
- GKT137831
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Calliditas Therapeutics AB
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