Active clinical trials for "Hepatitis B"

The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral doses of EYP001a in subjects with chronic HBV infection.

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated 626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although resection and transplantation offer the best 5-year survival rates, not all patients are suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI), radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate among HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease and highlights the necessity of finding new treatments or modifying the current treatment. The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350 million individuals with chronic, long-term liver infections. Patients with chronic HBV infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC. There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral and interferon drugs, such as Entecavir and Interferon α therapy, which can help some patients. However, these drugs are costly, thousands of dollars per year, and are not widely available in many countries, especially in the developing world. Vaccination is available and effective and is recommended for all individuals at risk for HBV infection. However, vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B is closely linked to liver cancer, which is almost always fatal. MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice and humans. The present study was carried out to examine whether combining the current conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may improve the outcome of the disease and increase the survival rate of patients with HCC or HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran will augment the therapeutic effect seen when patients are treated with conventional therapy alone.

The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD) taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy