Active clinical trials for "Hepatitis"

The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.

This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.

More than two billion individuals have serological evidence of hepatitis B virus (HBV) infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000 hepatitis B related deaths occur annually. Currently available hepatitis B vaccines are extremely safe and have an efficacy of >90 percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be eradicated through global vaccination. A positive immune response to the vaccine is defined as the development of hepatitis B surface antibody (anti-HBs) at a titer of >10 mIU/mL. Although anti-HBs titers decrease with time, the duration of protection is long. Protection has been estimated to persist for up to 22 years after the primary vaccination schedule. Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is probably due to the priming of memory cells, which are capable of eliciting an anamnestic response when challenged. This is supported by the rapid increases in anti-HBs titers in previously vaccinated individuals who administered booster injections.

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

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 most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

The investigators will identify possible participants using our database of previously treated hepatitis c patients. The investigators will identify those who have documented evidence of current injecting drug use as a risk factor for acquisition of the virus. The investigators will then search for those who have received curative treatment between 2004-2010. This covers all patients in the current database. The investigators will include those over 18 years old. The investigators will exclude those patients who are coinfected with either hepatitis B or HIV. This is because both of these conditions can accelerate liver damage when in combination with hepatitis c. The possible participants identified will be sent an information sheet giving a simple and clear outline of the proposed research. The investigator will try to obtain an au to date residential address from the PAS system in the NHS or through confirmation from the patients GP or drug worker. It will explain the purpose of the study, why they have been chosen, what taking part will involve, the potential advantages and disadvantages of taking part and that everything will be kept confidential. It will also outline who is conducting the study, how any expenses will be paid and contact details for any problems/complaints that arise. Those interested in taking part will attend an appointment at the hospital after they have had the opportunity to read through the information leaflet. They will be given time to ask any questions they have about the study and have them answered fully. They will then be asked to sign two copies of a consent form in order to take their participation any further. Once this is complete they can have their first 'liver assessment'. The assessment will take approximately 30-45 minutes to complete. The investigators will take three blood samples from them (approximately 10mls of blood or 4 teaspoons full). One sample is to measure the levels of hepatitis C virus in the blood. This will tell us whether there has been reinfection with hepatitis C. The second sample is to measure the levels of inflammation within the liver and the third sample is to measure the full blood count. The investigators will then perform a liver scan called a fibroscan. This is a noninvasive test similar to an ultrasound (that pregnant women have) and gives a reading that can tell us about any 'stiffness' in the liver. It takes approximately five to ten minutes to complete and involves the patient lying on their back with their right arm above their head for the duration of the scan. Following the scan the investigators will ask the participant to complete a short questionnaire. This will include questions about past and current drug use as well as any alcohol use. The answers will be kept strictly confidential. They will be stored in the researchers locked office and have no direct participant identifiers on them. They will simply have a study number on them.The participant will then be thanked for their time and offered £30 to cover all travel and time expenses for their visit. They will be invited to attend for a further liver assessment one year after their first one and annually thereafter. This is optional and they are of course free to withdraw from the study at any time without needing to give a reason. The investigators will be identifying participants at different points in time following their curative treatment. For example some will have been cured 5 year ago whereas other will have been cured 6-12 months ago. This will increase the number of patient years follow up. Once the investigators have done the first set of liver assessment the participants will then be followed prospectively for as long as they wish to participate. For the purpose of my higher degree I will present the data I have following two years of 'liver assessments'.

Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area like Taiwan, where there are more than 3 million chronic hepatitis B carriers. Patients with chronic HBV infection are at increased risk of developing cirrhosis, which may have disastrous complications, including hepatic decompensation, and hepatocellular carcinoma (HCC). The liver cirrhosis related complications accounts for the 8th leading cause of deaths in Taiwan; whereas, the HCC is the 2nd leading cause of deaths among all cancers. Therefore, it is prudent to develop strategies to prevent or halt the progression of liver cirrhosis. For HBV patients who have already had cirrhosis, the main treatment objective is to reduce their risk of complications. A large-scale multicenter clinical trial showed that viral suppression using lamivudine in patients with advanced fibrosis effectively decreases the risk of HCC and liver-related complications. This study highlights the importance to treat HBV-related cirrhosis patients; however, several issues remain to be addressed. The first issue is that this clinical trial only enrolled patients with positive HBeAg or HBV-DNA level >1.4 x105 IU/mL. However, the current recommended threshold for cirrhotic patients to start anti-viral treatment is 2000 IU/mL. Whether anti-HBV therapy benefits cirrhotic patients in this level is still unclear. Second, lamivudine was used in this clinical trial; however, the high resistant rate of lamivudine during treatment probably lowers its protective effect against HCC. Whether a more potent anti-HBV agent with extremely low resistance profile, entecavir, is more beneficial to HBV-related cirrhotic patients is also unclear. The Bureau of National Health Institute launched the reimbursement program for anti-HBV therapy since 2003 and extended this program to cirrhotic patients with HBV DNA level > 2000 IU/mL for long-term use since Aug, 2010. Taking this advantage, we may explore the above-mentioned clinical questions more easily. To address these issues, we will first retrospectively collect a cohort of HBV-related cirrhosis patients. All the patients will be enrolled from the time before oral anti-HBV therapy is widely used. We will determine their baseline serum HBV-DNA levels using the stored sera and enrolled those with baseline HBV-DNA levels higher than 2000 IU/mL as our historical controls. Second, we will enroll a retrospective cohort of HBV-related cirrhotic patients from 2008 who had HBV-DNA levels higher than 2000 IU/mL and received indefinite therapy of entecavir. By comparing these two cohorts, we will be able to clarify whether indefinite viral suppression by entecavir is beneficial for the cirrhotic patients. With comprehensive analysis, we wish to document that re-setting the risk level of HBV DNA from 140,000 IU/mL to 2,000 IU/mL is more beneficial for HBV-related cirrhotic patients and long-term entecavir does lower the risk of HCC further. These lines of evidence will assist in delivering appropriate and more aggressive treatment for these high-risk patients.

The aim of this study is to investigate the relationships between interleukin 28B genetic variants and the response to treatment of chronic hepatitis C in Chinese children.

The purpose of this study is to determine whether the outcome of interferon therapy on HCV infected patients can be early precisely predicted with a novel mathematic method with Chinese population.