Active clinical trials for "Hepatitis A"

This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.

In this study HCV negative recipients will be transplanted with HCV positive lungs. Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs. It is planned to enrolled 20 patients from the Lung transplant wait list in this study. Patients will be followed for 6 months. This will be a single center pilot study.

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).

A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.

An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis

This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

Severe Alcoholic hepatitis, defined by modified Maddrey's Discriminant Function (DF) ≥32, is associated with significant morbidity and mortality.(1,2) Of the various treatment modalities evaluated for treatment of Severe Alcoholic hepatitis, corticosteroids have been the most extensively studied.(1) Five out of 13 randomized controlled trials, and four out of 5 meta-analysis have shown a survival benefit with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.(1-4) However, the role of corticosteroids in Severe Alcoholic hepatitis still remains controversial.(5-6) Corticosteroid therapy is not considered the ideal option by most authors because their beneficial effect seems to be confined to a highly select minority group in which the inhibitory effect of corticosteroids on liver inflammation is not outweighed by side effects such as weakened defence against infections, anti-anabolic effects, and possible ulcer promoting effects.(6) Corticosteroids are usually contraindicated in those with DF > 54 or MELD >24 (7) .Also corticosteroids are contraindicated in those with renal failure, gastro-intestinal bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to evaluate new therapies for Severe Alcoholic hepatitis (SAH). In a recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one month survival in patients with Severe Alcoholic hepatitis, compared with glucocorticoids alone. However, the 6 month survival similar in both the groups.(8) Human colostrum and bovine colostrum are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent studies suggest that colostrum components, immunoglobulin and growth factor benefits physically active person as well as in the treatment of autoimmune disorders. It is used for the treatment of a wide variety of gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut injury, Helicobacter pylori infection, immune deficiency related diarrhea as well as infective diarrhea.(9,10,11) It has also been sucessfully used to significantly decrease the level of Endotoxemia - lower levels of Lipopolysaccharides. We plan to compare the efficacy of bovine colostrum versus Placebo (Pasteurized milk powder) alone in treatment of severe alcoholic hepatitis. Bovine Colostrum is rich in protein, immunoglobulin, lactoferrin and growth factors. Recent studies suggest that Colostrum components, immunoglobulin and growth factor benefits physically active person and in treatment of autoimmune disorders. It is used for the treatment of a wide variety of gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut injury, H pylori infection, immune deficiency related diarrhea as well as infective diarrhea.(9) The guidelines by American College of Gastroenterology (10) and other authors (11) have suggested that a combination of Corticosteroids and other drugs, which have different mechanisms of action, may be more beneficial for reducing mortality in severe alcoholic hepatitis. Hence, the investigators plan to compare the efficacy of combined therapy of Corticosteroids and Bovine colostrum versus Corticosteroids alone in treatment of severe alcoholic hepatitis.

There is a huge gap between the clinical efficacy and community effectiveness in the treatment of chronic hepatitis C in Taiwan. HCV infection prevails in uremic patients with the prevalence of > 10 % in Taiwan.The current study will be executed in each participating hemodialysis centers by an outreach team of HCV treaters, treating all of the HCV-viremic uremia patients and HD staffs at the same time (group therapy) in each individual HD center (Erase-C campaign) with all oral directly-acting antivirals, to ensure the rates of diagnosis, accessibility, treatment and follow-up.The purpose of the study is to demonstrate a model of care using outreach HCV treaters by implementing the concept of "group therapy" with one-size-fit-all pangenotypic DAA regimen, 12 weeks of sofosbuvir/velpatasvir, in each individual hemodialysis center (Erase-C campaign) to achieve HCV micro-elimination.

The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase hepatitis C virus (HCV) treatment access and delivery in a rural Appalachian community, which is in the midst of the opioid/hepatitis C (HCV) syndemic. KeY Treat is a clinical research study seeking to determine whether removing barriers (cost, insurance, specialist, abstinence) associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV will impact health in Perry County, Kentucky.