Primary Biliary Cholangitis (PBC) research hub
7 indexed studies · 5 currently recruiting
- recruitingTherapeutic confirmatory (Phase III)
A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants with Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid
This study is testing a medicine called elafibranor for adults with primary biliary cholangitis (PBC). It is for people whose regular treatment has not worked well enough or caused side effects. Researchers want to see if elafibranor can safely bring liver test results back to normal, healthy levels.
Germany · Poland · Czechia - recruitingPhase I and Phase II (Integrated)- Other
A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction.
This study tests a new medicine called golexanolone for adults with primary biliary cholangitis (PBC). Researchers want to see if the treatment is safe and whether it can help relieve severe tiredness and 'brain fog', which are common, distressing symptoms that currently have few good treatments.
Hungary · Spain · Italy - authorisedPhase III and phase IV (Integrated)
A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
This study is looking at a medicine called saroglitazar magnesium for people living with primary biliary cholangitis (PBC). Researchers want to see if this daily tablet can protect the liver from long-term damage, reduce extreme tiredness, and lower the risk of serious complications or needing a liver transplant.
Ireland · Greece · Estonia - recruitingTherapeutic exploratory (Phase II)
A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
This study is testing new combinations of medicines for a liver condition called Primary Biliary Cholangitis (PBC). We want to see if these combinations are safe and work better than current treatments, especially for people who haven't responded well to their usual medication.
Germany · Norway · Hungary - recruitingPhase II and Phase III (Integrated)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis
This study is testing a new medicine, Saroglitazar Magnesium, for people with Primary Biliary Cholangitis (PBC). Researchers want to see if it improves liver test results and is safe. Some people will get the medicine, others will get a dummy pill.
Iceland - recruitingTherapeutic confirmatory (Phase III)
A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis
This study looks at a new drug combination for Primary Biliary Cholangitis (PBC). It checks if mixing two existing medicines, Obeticholic Acid and Bezafibrate, helps liver health over a long time. Researchers want to see how safe and effective this combination is for patients.
Netherlands · France · Norway - active not recruitingPHASE1, PHASE2
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
This study is testing a new medicine, golexanolone, for people with Primary Biliary Cholangitis (PBC) who feel very tired and have problems with their thinking. It aims to see if the medicine is safe and helps with these symptoms.
Germany · Greece · Hungary