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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: 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: NCT05624294 Completed - Clinical trials for Primary Biliary Cholangitis

Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects

Start date: December 19, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.

NCT ID: NCT05292872 Completed - Clinical trials for Primary Biliary Cholangitis

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

HEROES PBC
Start date: March 28, 2022
Phase:
Study type: Observational

This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria will be considered for this study.

NCT ID: NCT05190523 Completed - Clinical trials for Primary Biliary Cholangitis

Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Start date: April 6, 2022
Phase: Phase 2
Study type: Interventional

This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04604652 Completed - Clinical trials for Primary Biliary Cirrhosis

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

PRONTO-PBC
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

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. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.

NCT ID: NCT03954327 Completed - Clinical trials for Primary Biliary Cholangitis

Combination Antiretroviral Therapy (cART) for PBC

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

Placebo Controlled, double-blind randomized controlled trial (RCT) with 12 months Tenofovir Disoproxil and Raltegravir for primary biliary cholangitis (PBC) patients unresponsive to Ursodeoxycholic Acid (UDCA). Placebo patients will be offered 12 months open label therapy at unblinding. All patients will be offered an additional 12 months open label therapy. Observational, open label study will be performed in parallel using Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & Raltegravir in liver transplant recipients meeting all entry criteria except for use of immunosuppression.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03545672 Completed - Clinical trials for Primary Biliary Cholangitis

Early Identification of Myocardial Impairment in PBC

EARLY-MYO-PBC
Start date: September 1, 2017
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently developed as a reliable modality to evaluate the cardiac tissue characteristics and functions. This study aims to investigate the cardiac status in PBC patients based on CMR.