Chronic Liver Diseases (CLD)

Also known as: Liver Disease Chronic / Focal liver disease / Chronic Liver Diseases / Chronic Liver Disease (CLD) / Chronic Liver Disease / Diseases of liver (K70-K77) / Hepatic pathology / Fector hepaticus / [X]Diseases of the liver / Hepatopathy / Hepatic disease NOS / Hepatic disorder (NOS) / Disorder hepatic / Hepatic disorder NOS / Disease hepatocellular / Disorder liver / Hepatic disease / Hepatic disease (NOS) / Liver disorder / Liver Diseases / Unspecified disorder of liver

DrugDrug NameDrug Description
DB13125LusutrombopagLusutrombopag is an orally bioavailable thrombopoietin receptor (TPOR) agonist developed by Shionogi & Company (Osaka, Japan). TPOR is a regulatory target site for endogenous thrombopoietin, which acts as a primary cytokine to promote megakaryocyte proliferation and differentiation, and affect other hematopoietic lineages as well, including erythroid, granulocytic and lymphoid lineages [A36736]. Thrombocytopenia, which indicates abnormally low levels of platelets, is a common complication related to chronic liver disease. This hematological abnormality, especially in cases of severe thrombocytopenia (platelet count <50,000/μL), creates challenges to patients requiring invasive medical procedures where there is a significant risk for spontaneous bleeding [A36732]. Lusutrombopag binds to the transmembrane domain of TPOR expressed on megakaryocytes, and causes the proliferation and differentiation of megakaryocytic progenitor cells from hematopoietic stem cells [FDA Label]. In September 2015, lusutrombopag received its first global approval in Japan to reduce the need for platelet transfusion in adults with chronic liver disease and thrombocytopenia who are schedule to undergo an invasive medical procedure [A36730]. Lusutrombopag was approved by the FDA on July 31st, 2018 for the same therapeutic indication under the market name Mulpleta. In two randomized, double-blind, placebo-controlled trials, patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure with a platelet count less than 50 x 10^9/L were administered lusutrombopag orally [L4166]. Higher percentages (65-78%) of the patients receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure compared to those receiving placebo [L4166]. Lusutrombopag is currently in phase III development in various European countries including Austria, Belgium, Germany, and the UK [A36730].
DB13968Plasma protein fraction (human)The plasma protein fraction human (PPFh) is defined as a sterile solution of proteins composed mainly of albumin and globulin derived from human plasma.[A32512] It is already reviewed under the category of biologics by the FDA where the processing, required tests, requirements and labeling are incorporated. This biologic should come from recovered plasma from whole blood or prepared source plasma. the final product should not include any type of additives. The composition of PPFh should be 5% of protein from which 83% should consist of albumin and no more of 17% should be globulin. It is also stated that no more than 1% of the total protein should be gamma globulin.[L2260] PPFh is a sterile, frozen solution of solvent/detergent treated human plasma.[L2262] The proteins in PPFh are stabilized with sodium caprylate and acetyltryptophan and it contains some electrolytes such as sodium, potassium and chloride.[L2261]
DrugDrug NamePhaseStatusCount
DB04519Caprylic acid2Terminated1
DB00930Colesevelam2 / 3Completed1
DB00581Lactulose2 / 3Completed1
DB00571Propranolol2 / 3Unknown Status1
DB12475Biphenyl dimethyl dicarboxylate3Completed1
DB06705Gadofosveset trisodium4Completed1
DB00008Peginterferon alfa-2a4Completed1
DB00022Peginterferon alfa-2b4Completed1
DB01261Sitagliptin4Unknown Status1
DB01586Ursodeoxycholic acid4Unknown Status1
DB03793Benzoic acidNot AvailableCompleted1
DB01136CarvedilolNot AvailableCompleted1
DB09150Fludeoxyglucose (18F)Not AvailableNot Yet Recruiting1
DB09083IvabradineNot AvailableCompleted1
DB01277MecaserminNot AvailableWithdrawn1