Primary Biliary Cirrhosis Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).
Primary biliary cholangitis (PBC) is a disease of the liver. It is caused a sustained attack by the body's immune system on the bile ducts (canals) inside the liver. This continuous assault leads to their gradual destruction and eventual disappearance. This results in obstruction to the flow of bile which gets worse with disease progression. Once the bile duct injury has been established, the disease progresses due to ongoing obstruction of bile flow, inflammation and scarring of the liver tissue(fibrosis). The liver eventually fails. This research is looking into whether the study drug is better than a dummy drug when given to patients with PBC. This trial will monitor the patients taking part with regular blood tests and ultrasound liver scans before, during, and at the end of the trial. These measures will allow for the ongoing assessment of liver function, and liver stiffness. It is hoped that in patients in whom the study drug is beneficial, the liver function or stiffness may progress at a slower pace, or may even improve during or at the end of the trial. Liver injury, inflammation and fibrosis Participants will be randomly assigned to 1 of 3 treatment groups (active drug once daily, active drug twice daily or placebo). This is a double blinded study so neither the participants nor the staff responsible for their care will know which group they have been assigned to. During the treatment period, participants will take 4 capsules orally at home in the morning and 4 capsules in the evening for 24 weeks. Participants will be in the trial for 32 weeks in total (about 8 months) and will attend approximately 8 clinic visits. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04526665 -
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
|
Phase 3 | |
Recruiting |
NCT02931513 -
sCD163 in PBC Patients - Assessment of Treatment Response
|
||
Active, not recruiting |
NCT02924701 -
sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
|
||
Completed |
NCT02659696 -
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
|
||
Completed |
NCT02078882 -
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
|
Phase 4 | |
Completed |
NCT01389973 -
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
|
Phase 2 | |
Completed |
NCT01603199 -
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
|
N/A | |
Completed |
NCT01857284 -
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
|
Phase 3 | |
Completed |
NCT05374200 -
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)
|
N/A | |
Recruiting |
NCT02937012 -
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
|
Phase 3 | |
Completed |
NCT02376335 -
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis
|
Phase 2 | |
Recruiting |
NCT01662973 -
Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04751188 -
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
|
Phase 3 | |
Recruiting |
NCT04514965 -
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
|
||
Recruiting |
NCT03668145 -
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis
|
N/A | |
Completed |
NCT02955602 -
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
|
Phase 2 | |
Completed |
NCT02557360 -
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
|
Phase 4 | |
Recruiting |
NCT01440309 -
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
|
Phase 1 | |
Completed |
NCT01249092 -
Pentoxifylline for Primary Biliary Cirrhosis
|
Phase 2 | |
Completed |
NCT01510860 -
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
|
Phase 4 |