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Hepatitis, Chronic clinical trials

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NCT ID: NCT02337127 Recruiting - Chronic Hepatitis B Clinical Trials

Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

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

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.

NCT ID: NCT02327416 Recruiting - Clinical trials for Hepatitis B, Chronic

A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)

Start date: October 2014
Phase: Phase 3
Study type: Interventional

This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to assess the efficacy and safety of combination and sequential treatment with Y peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides experienced. Patients were randomized to one of 3 groups to receive different antiviral treatment.

NCT ID: NCT02287857 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B

Start date: September 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02171949 Recruiting - Hepatic Cirrhosis Clinical Trials

Clinical Trial for Evaluation of Treatment With Multiple Infusions of Mononuclear Bone Marrow Cells in Patients With Chronic Liver Diseases

Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of multiple infusions of mononuclear bone marrow cells in patients with chronic liver diseases.

NCT ID: NCT02167503 Recruiting - Chronic Hepatitis B Clinical Trials

Observational Study on Patients With Chronic Hepatitis B

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

The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.

NCT ID: NCT02126137 Recruiting - Chronic Hepatitis C Clinical Trials

Pilot Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection

EZE-1
Start date: October 2013
Phase: Phase 1
Study type: Interventional

Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and 80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause for liver transplantation in Chile. Even though treatments are evolving with new direct antiviral agents (DAAs) that are increasing response rates, there are several issues with these new approaches, including increased toxicity, need for using interferon and ribavirin, complex algorithms of treatment, high cost, limited effectivity in certain groups (liver transplant patients) and drug interactions. Treatments targeted at host factors required for the viral cycle are becoming increasingly explored as an alternative or complement to DAAs. It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an approved and generally safe drug used for the management of hypercholesterolemia. Our hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20 mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV RNA and core antigen in plasma, bile and feces.

NCT ID: NCT02057887 Recruiting - Clinical trials for Chronic Hepatitis C Virus Genotype I

Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

NCT ID: NCT02038387 Recruiting - Clinical trials for Non Alcoholic Fatty Liver Disease

Prospective Clinical Study of the Role of the Immune Response, in Relation to Diet, in Patients Affected by Either Chronic Hepatitis C Virus (HCV) Infection or Non Alcoholic Fatty Liver Disease (NAFLD)

Start date: July 2012
Phase: N/A
Study type: Interventional

Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are characterized by a spectrum of pathological conditions ranging from an early stage of inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large differences in age and ethnic groups, while it is well known that HCV infection is a major cause of chronic liver disease in Western countries. For both diseases the progression of liver damage is in close correlation with the lifestyle of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was shown that feeding imbalances may have implications in altering the normal immune functions of the subjects, suggesting that the metabolic and the immune systems are closely related to each other. Although it is well known the negative role of obesity on the progression of NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to the immune response is not yet fully understood. Insulin resistance, altered lipid metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection. Recent studies suggest that the evolution of viral infections and chronic inflammation in NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17 (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV infection in the activation of Th17 cells and in the alteration of some of their functions, will allow to shed light on the pathogenic mechanisms underlying the progression of immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17 cells may have a role in the diminished response to therapy in patients who have high cholesterol levels. If the results will confirm our hypothesis, this study will provide useful informations for the clinical management of patients with both steatosis and chronic HCV infection. The data obtained can also be used for the development of new therapeutic strategies directed to modulate the antiviral immune response. All patients will undergo clinical and instrumental assessment depending on the type of pathology. Patients will be required to follow a normocaloric low cholesterol diet for a period of 30 days. The prospective clinical study does not present any form of additional risk for the patients and will be conducted in accordance with the principles established by the Declaration of Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require any additional costs.

NCT ID: NCT02017587 Recruiting - Chronic Hepatitis B Clinical Trials

Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection

Start date: December 2013
Phase: N/A
Study type: Observational

The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from approximately 40 chronic HBV for biomedical research program led by VGTI Florida.

NCT ID: NCT01998620 Recruiting - Hepatitis B Clinical Trials

Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Start date: November 2013
Phase: Phase 4
Study type: Interventional

This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.