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Primary Biliary Cholangitis clinical trials

View clinical trials related to Primary Biliary Cholangitis.

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NCT ID: NCT06309589 Completed - Clinical trials for Primary Biliary Cholangitis

The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.

NCT ID: NCT06247735 Recruiting - Clinical trials for 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.

Start date: January 26, 2024
Phase: Phase 2
Study type: Interventional

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

NCT ID: NCT06174402 Recruiting - Clinical trials for Primary Biliary Cholangitis

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Start date: August 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

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)

NCT ID: NCT06098027 Completed - Clinical trials for Primary Biliary Cholangitis

Study of [14C]CS0159 in China Healthy Subjects

Start date: October 23, 2023
Phase: Phase 1
Study type: Interventional

Study of [14C]CS0159 in China Healthy Subjects.

NCT ID: NCT06060665 Recruiting - Clinical trials for Primary Biliary Cholangitis

IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

IDEAL
Start date: September 5, 2023
Phase: Phase 3
Study type: Interventional

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

NCT ID: NCT06051617 Recruiting - Clinical trials for Primary Biliary Cholangitis

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

AFFIRM
Start date: September 7, 2023
Phase: Phase 3
Study type: Interventional

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

NCT ID: NCT05919433 Recruiting - Clinical trials for Primary Biliary Cholangitis

Detection Program for Patients With Primary Biliary Cholangitis Lost in the System

RESCAT
Start date: May 1, 2023
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance. According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer >1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis). The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively. The objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.

NCT ID: NCT05786482 Recruiting - Cancer Clinical Trials

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

EMPOwer
Start date: February 12, 2023
Phase: N/A
Study type: Interventional

Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

NCT ID: NCT05751967 Recruiting - Clinical trials for Primary Biliary Cholangitis

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Start date: February 22, 2023
Phase: Phase 3
Study type: Interventional

Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.

NCT ID: NCT05749822 Recruiting - Clinical trials for Primary Biliary Cholangitis

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Start date: February 17, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

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).