Active clinical trials for "Hepatitis, Chronic"

The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed

Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL).

Most patients with Chronic Hepatitis B are on nucleoside analogy (NA) long term, but this leads to HBsAg loss (defined as functional cure) of only 2% at 6 years. Recently a number of studies have shown significant HBsAg loss rates after stopping nucleoside analogues (NA). However, no criteria to select such patients have been evaluated. Consequently, the objective of the study is not only to determine the proportion of patients able to achieve HBsAg loss in those with qHBsAg≤100IU/ml. The study is designed as a randomised control trial with 1:2 parallel arm randomisation to continuing NA or stopping therapy. Patients will be monitored after stopping therapy for Hepatitis B flares and also to document HBsAg loss.

The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB patients who have been on anti-HBV drugs but with poor effects, supposing to significantly improve anti-HBV efficacy, even to clean HBV from the patients.

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.

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

Lamivudine had been widely used for treatment-naïve chronic hepatitis B patients. However, development of antiviral resistance has been known as the major drawback: Incidence of lamivudine resistance was reported to be approximately 70% after 5 years (Lok AS et al, 2003). For the treatment of lamivudine resistance, adefovir has been widely used (Lok AS and McMahon B, 2009). However, switching to adefovir monotherapy was also reported to be at high risk of resistance, 25% at year 2 (Yeon JE et al, 2006). Recently, adding adefovir on lamivudine was shown to be superior to switching to adefovir monotherapy by decreasing the adefovir resistance (Rapti I et al, 2007, Lampertico P et al, 2007). However, combination of adefovir and lamivudine does not increase antiviral activity compared with adefovir monotherapy in patients with lamivudine resistance (Peters MG et al, 2004). As many patients are still viremic with the treatment of lamivudine and adefovir over 1 year, the investigators need more potent combination of the drugs. Telbivudine is a new nucleoside analogue with potent antiviral activity. The previous phase III study has shown the superiority of telbivudine over lamivudine in HBeAg positive and negative subjects (Lai CL et al, 2007). Therefore, telbivudine plus adefovir may be a better treatment option than lamivudine plus adefovir for the lamivudine-resistant chronic hepatitis B patients. No study assessing the efficacy of telbivudine plus adefovir has been conducted for these patients. The aim of this study is to evaluate the safety and efficacy of telbivudine plus adefovir compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients at the end of 1 year follow-up,