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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: NCT02924701 Active, not recruiting - Clinical trials for Primary Biliary Cirrhosis

sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis

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. 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 correlate with disease severity in patients with PBC, and whether sCD163 and sMR can predict short term disease progression, changes in quality of life and death in these patients.

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: NCT02846896 Completed - Clinical trials for Primary Biliary Cirrhosis

The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Start date: December 2015
Phase: N/A
Study type: Observational [Patient Registry]

PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.

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: NCT02823353 Completed - Clinical trials for Primary Biliary Cirrhosis

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Start date: April 8, 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (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: NCT02659696 Completed - Clinical trials for Primary Biliary Cirrhosis

Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis

Start date: September 2015
Phase:
Study type: Observational

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

NCT ID: NCT02557360 Completed - Clinical trials for Primary Biliary Cirrhosis

Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis

Start date: November 2015
Phase: Phase 4
Study type: Interventional

Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to several symptoms such as intractable pruritus or chronic fatigue, significantly impairing patients quality of life. Recent studies show, that chronic liver diseases are associated with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for the synthesis of SAMe from methionine. SAMe deficiency is associated with impaired detoxification and hepatoprotection and exacerbate liver injury. Supplementation with SAMe has proven useful in several liver diseases. The study group will include 20 patients with PBC diagnosed with European Association for the Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic acid (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months. Both clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and urine bile acids metabolites, transient elastography and health related quality of life.

NCT ID: NCT02477462 Completed - Clinical trials for Primary Biliary Cirrhosis

Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients

Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high titers of serum anti-mitochondrial autoantibodies (AMA) directed against the pyruvate dehydrogenase complex E2 subunit and evidence from both human and murine models suggests that T-cells, particularly cluster of differentiation (CD) 8+ T cells, are key to the destruction of bile ducts. However, clinical trials of classic immunosuppressive drugs including corticosteroids, azathioprine, methotrexate, and tacrolimus have been largely unsuccessful in altering the disease course. This is a single center, prospective, non-treatment study of the role of immune responses in PBC patients. Non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic steatohepatitis (NASH) are common, often "silent" liver diseases. NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and fibrosis. NASH can be severe and can lead to cirrhosis and hepatocellular carcinoma. Ten to 20 percent of American have NAFLD with NASH affecting 2 to 5 percent of Americans.