View clinical trials related to Hepatitis.
Filter by:Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide afflicting 350 million persons, leading to significant morbidity and mortality due to liver disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this rescued patients with significant risk of disease progression, but in most circumstances, therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite disappointing. However a recent showed that the combination of telbivudine and tenofovir in a response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in patients. Such results require further confirmation. There is currently an unmet need for the large number of patients on long term nucleoside analogue therapy who have not achieved HBeAg seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long term therapy hence an exploration of other therapeutic strategies is attractive. An additional benefit of telbivudine has been the surprising improvement in renal function and this study seeks to examine whether this can improve the renal impairment that may be seen with tenofovir. Our study proposes to examine if the combination of tenofovir and telbivudine can improve endpoints. Patients fulfilling inclusion and exclusion criteria will be randomized to tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint will be a qHBsAg reduction of >1log at week 96, which may predict future HBsAg seroclearance, which is also a secondary endpoint. An additional primary endpoint is increase in eGFR in the combination arm compared to the monotherapy arm. The study aims to enroll 146 patients randomized 1:1 ratio (73:73) patients. Multivariate analysis will be performed of baseline and on-treatment factors that predict the primary outcome.
This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection.
The natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Disease monitoring and treatment will be provided following current WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis.
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
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.
Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.
ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate: 1. Alcohol use 2. Dietary intake 3. Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival. The study is intended to explore potential precipitants of alcoholic hepatitis.
The aim of the present study is to estimate the national annual prevalence and incidence of current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid substitution treatment (OST) based on a representative sample of approximately 2,500 outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to describe factors influencing HCV therapy initiation and seroconversion during OST.
The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient populations: 1. Treatment-naïve patients, with and without cirrhosis (Group 1) 2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2) 3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.