Clinical trials: Primary Biliary Cirrhosis, active
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 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
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
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
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, 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 Biliary Cholangitis
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
- Trial name
- EPICS-V (NCT07216235)
- Testing
- Saroglitazar magnesium 1 mg
- Where
- 3 sites in United States
- Volunteers
- 386 people
- Sponsor
- Zydus Therapeutics Inc.
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
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
LEOPARD Prospective Validation Cohort 1
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 PVC1 (NCT06723275)
- Testing
- Standardized assessments, guided tumor biopsy and biobanking, Standardized assessments and biobanking
- Where
- 8 sites in Belgium, France and 3 more
- Volunteers
- 630 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid…
- Trial name
- NCT07282353
- Testing
- 2mg CS0159
- Where
- 42 sites in China
- Volunteers
- 135 people
- Sponsor
- Cascade Pharmaceuticals, Inc
Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC)
The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching
Cholestatic liver diseases are characterized by jaundice, pruritus, and elevated levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT).
- Conditions
- Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Atopic Dermatitis (AD)
- Trial name
- NCT07678645
- Testing
- Upadacitinib 15 MG
- Where
- China
- Volunteers
- 44 people
- Sponsor
- RenJi Hospital
Primary Biliary Cholangitis (PBC)
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC).
- Trial name
- NCT07631442
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
Primary Biliary Cholangitis, Liver Fibrosis
Patients With Primary Biliary Cholangitis(PBC)
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced…
- Conditions
- Primary Biliary Cholangitis, Liver Fibrosis, Cirrhosis, Liver, Blood Sugar; High
- Trial name
- GLYPP (NCT07629128)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS