Clinical trials: PBC
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
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 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 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
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, Primary Sclerosing Cholangitis
The Effect of Bezafibrate on Cholestatic Itch
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
- Conditions
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- Trial name
- FITCH (NCT02701166)
- Testing
- Bezafibrate
- Where
- 9 sites in Netherlands, Spain
- Volunteers
- 84 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Liver Cirrhosis, Biliary
Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk.
- Trial name
- CBP-HOPE (NCT03630718)
- Testing
- Psychoeducational Intervention, Hypnosis intervention
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
PBC, Primary Biliary Cholangitis (PBC)
Epidemiology of PrImary Biliary Cholangitis in Spain
Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant.
- Trial name
- EPIC-PBC (NCT07821463)
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Fundacio Privada Mon Clinic Barcelona
Primary Biliary Cholangitis
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT06365424
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cholangitis
Fenofibrate for Compensated Cirrhosis Patients With 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
- NCT05749822
- Testing
- Fenofibrate 200mg, UDCA
- Where
- 12 sites in China
- Volunteers
- 104 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
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
SCAD, Addison Disease
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.
- Conditions
- SCAD, Addison Disease, Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome
- Trial name
- NCT03941184
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02026401
- Testing
- NGM282
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Biliary Cirrhosis, Primary
IBAT Inhibitor A4250 for Cholestatic Pruritus
This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250
- Trial name
- NCT02360852
- Testing
- A4250
- Where
- Sweden
- Volunteers
- 9 people
- Sponsor
- Sahlgrenska University Hospital
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 Biliary Cirrhosis
Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free…
- Trial name
- NCT02916641
- Testing
- Fuzhenghuayu, UDCA
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
LEOPARD Training and Validation Data Collection Study
Intro: The present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT)…
- Conditions
- Decompensated Liver Cirrhosis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Hepato-cellular Carcinoma
- Trial name
- LEOPARD TVDCS (NCT06675604)
- Where
- 53 sites in Austria, Belgium and 5 more
- Volunteers
- 4,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
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