Clinical trials: Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC)
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a…
- Trial name
- ELFIDENCE (NCT06016842)
- Testing
- Elafibranor
- Where
- 198 sites in United States, Argentina and 26 more
- Volunteers
- 276 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
- Trial name
- ELFINITY (NCT06447168)
- Where
- 72 sites in United States, Australia and 9 more
- Volunteers
- 424 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC.
- Trial name
- ELONSEN (NCT06730061)
- Testing
- Elafibranor
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Ipsen
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
Primary Sclerosing Cholangitis, Ulcerative Colitis
Gluten-free Diet in PSC and IBD
Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries.
- Conditions
- Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract
- Trial name
- NCT06026449
- Testing
- Gluten-free diet
- Where
- Czechia
- Volunteers
- 51 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
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
- 217 sites in United States, Argentina and 27 more
- Volunteers
- 402 people
- Sponsor
- Gilead Sciences
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
- Conditions
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis, Cholestasis
- Trial name
- NCT07843420
- Testing
- Nemolizumab-ilto
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- EPICS-III (NCT05133336)
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- 57 sites in United States, Argentina and 2 more
- Volunteers
- 196 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Biliary Cholangitis
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
- Trial name
- EPICS-IV (NCT07424677)
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Zydus Therapeutics Inc.
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
Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC)
Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease, Primary Sclerosing Cholangitis (PSC)
- Trial name
- DISTAL (NCT07784881)
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Nantes University Hospital
Primary Biliary Cholangitis
Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis
This phase I/II clinical trial evaluates human umbilical cord-derived mesenchymal stromal cell (hUC-MSC) injection in patients with primary biliary cholangitis (PBC).
- Trial name
- MSC-PBC-I/II (NCT07795151)
- Testing
- Standard background therapy, hUC-MSC Dose Level 1, hUC-MSC Dose Level 2
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Beijing 302 Hospital
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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 Sclerosing Cholangitis, Cholangitis
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
- Conditions
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases
- Trial name
- NCT03678480
- Testing
- HTD1801, Ursodeoxycholic Acid
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Autoimmune Liver Disease, Autoimmune Hepatitis
TruGraf Liver Gene Expression Serial Test
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months…
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT06061341
- Testing
- TruGraf®
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Washington University School of Medicine
Primary Biliary Cholangitis (PBC)
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.
- Trial name
- NCT06591455
- Testing
- Fenofibrate, UDCA (Ursodeoxycholic acid)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Han Ying