View clinical trials related to Chronic Hepatitis B.
Filter by:This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference. Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
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 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 aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.
The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.
Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.
Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.