Clinical trials: Biliary Cirrhosis, Primary
Pruritus, Liver Cirrhosis, Biliary
Treatment of Cholestatic Pruritus With Sertraline
The goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are currently being enrolled in the study.
- Conditions
- Pruritus, Liver Cirrhosis, Biliary, Hepatitis C
- Trial name
- NCT00058903
- Testing
- sertraline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Liver Diseases, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Multiparametric MRI
This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS…
- Conditions
- Liver Diseases, Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- Trial name
- NCT03743272
- Testing
- LiverMultiScan
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Perspectum
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, Spleen Stiffness
The Value of Spleen Stiffness Measurement in Patients With PBC
Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC.
- Trial name
- NCT07319169
- Testing
- Spleen stiffness measurement
- Where
- Belgium
- Volunteers
- 125 people
- Sponsor
- Universitair Ziekenhuis Brussel
Primary Biliary Cirrhosis
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression…
- Trial name
- NCT04751188
- Testing
- Bezafibrate 200 MG Oral Tablet, Ursodeoxycholic Acid
- Where
- Mexico
- Volunteers
- 11 people
- Sponsor
- Instituto Mexicano del Seguro Social
Primary Biliary Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration of the bile ducts in the liver, leading to…
- Trial name
- NCT01088607
- Testing
- ursodeoxycholic acid (UDCA)
- Where
- 12 sites in United States
- Volunteers
- 27 people
- Sponsor
- University of Tennessee
Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
- Trial name
- NCT06427395
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- 28 sites in United States, Argentina and 1 more
- Volunteers
- 102 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Biliary Cirrhosis
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Up to 40% of patients with PBC have an inadequate response to standard treatment with UDCA, hence bezafibrate, a PPAR-agonist is being introduced as add-on therapy in these patients.
- Trial name
- NCT04514965
- Testing
- Blood sampling, Fibroscan, Question
- Where
- 2 sites in Denmark
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
Cholestatic Pruritus
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus.
- Trial name
- NCT03995212
- Testing
- CR845 1.0 mg
- Where
- 14 sites in United States
- Volunteers
- 14 people
- Sponsor
- Cara Therapeutics, Inc.
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
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
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)
- Trial name
- NCT06174402
- Testing
- Fenofibrate, UDCA
- Where
- 12 sites in China
- Volunteers
- 184 people
- Sponsor
- Han Ying
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
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis.
- Trial name
- AFFIRM (NCT06051617)
- Testing
- Seladelpar
- Where
- 218 sites in United States, Argentina and 27 more
- Volunteers
- 402 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis (PBC)
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment.
- Trial name
- NCT06591468
- Testing
- Prednisone, UDCA (Ursodeoxycholic acid)
- Where
- 2 sites in China
- Volunteers
- 244 people
- Sponsor
- Han Ying
Primary Biliary Cholangitis
A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life
Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.
- Trial name
- OCARELIFE (NCT03703076)
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- SAMEY
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
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