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Primary Biliary Cirrhosis clinical trials

View clinical trials related to Primary Biliary Cirrhosis.

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NCT ID: NCT02931513 Recruiting - Clinical trials for Primary Biliary Cirrhosis

sCD163 in PBC Patients - Assessment of Treatment Response

Start date: September 2016
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC. However, up to 40% of patients respond inadequate to this treatment. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR can predict response to treatment with UDCA in newly diagnosed patients with PBC.

NCT ID: NCT02916641 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

NCT ID: NCT02916290 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA (13—15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation. However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here the investigators start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

NCT ID: NCT02823366 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.

NCT ID: NCT02193360 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Pilot Study of FFP104 Dose Escalation in PBC Subjects

Start date: May 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC

NCT ID: NCT01793168 Recruiting - Clinical trials for Retinitis Pigmentosa

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS
Start date: July 2010
Phase:
Study type: Observational [Patient Registry]

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.

NCT ID: NCT01662973 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Primary biliary cirrhosis (PBC) is a slowly progressive disease that causes substantial loss of intrahepatic bile ducts, ultimately resulting in cholestasis, advanced fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma. Histologically, the disease is characterized by chronic portal inflammation with infiltration, destruction and loss of the epithelial cells in the small-sized and medium-sized bile ducts. Currently, Ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg/day is recommended as therapeutic drugs for PBC by AASLD and is approved for this indication by the U.S. Food and Drug Administration (FDA). Treatment with UDCA may delay disease progression and prolong survival free of liver transplantation. However, one out of three patients does not adequately respond to UDCA therapy and many need additional medical therapy or liver transplantation, or both. UC-MSC has been application for the treatment of several severe autoimmune diseases, such as immune thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis. In this study, the safety and efficacy of UC-MSC transplantation for PBC patients will be evaluated.

NCT ID: NCT01440309 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis

MSCsTreatPBC
Start date: November 2011
Phase: Phase 1
Study type: Interventional

The study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (PBC).