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Hepatitis B clinical trials

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NCT ID: NCT02463019 Enrolling by invitation - Chronic Hepatitis B Clinical Trials

Roll-over After 3-year Trial for Tenofovir in Mild Chronic Hepatitis B

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This open-label study is an roll-over extension of a randomized trial "Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight Aminotransferase Elevation" (NCT01522625). After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another 3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year open-label therapy. During the 3-year period, patients were followed up every 12 weeks for the biochemical, serological, virological parameters, and adverse reactions. The primary outcome is the progression of liver fibrosis. Safety issues such as change of renal function and bone mineral density are 2nd outcomes.

NCT ID: NCT02148562 Enrolling by invitation - Hepatitis B Clinical Trials

Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity

Start date: April 2014
Phase: N/A
Study type: Observational

In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.

NCT ID: NCT01957618 Enrolling by invitation - Clinical trials for Hepatitis B Virus-Related Hepatocellular Carcinoma

The Follow-up Study of Chronic Hepatitis B Patients With Liver Cirrhosis Receiving Anti-HBV Therapy

CTEAM
Start date: October 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01548326 Enrolling by invitation - Hepatitis B Clinical Trials

Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

NCT ID: NCT01342185 Enrolling by invitation - Chronic Hepatitis B Clinical Trials

Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

EMOTCHB
Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.

NCT ID: NCT00939068 Enrolling by invitation - Clinical trials for Chronic Hepatitis B, Gestation

Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

NCT ID: NCT00663182 Enrolling by invitation - Clinical trials for Decompensated Cirrhosis

Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.