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Hepatitis clinical trials

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NCT ID: NCT02257645 Not yet recruiting - Hepatitis B Clinical Trials

Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

Start date: March 2015
Phase: N/A
Study type: Observational

A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.

NCT ID: NCT02118597 Not yet recruiting - Clinical trials for Hepatitis C, Chronic

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Pegasys and Ribivarin in the Re-Treatment of Chronic Hepatitis C Patients

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

This prospective, national, multicenter, non-interventional study will examine the use of triple combination therapy with boceprevir, Pegasys and ribivarin in re-treating patients with genotype 1 CHC infection. Dosing and treatment duration are at the discretion of the investigator in accordance with local clinical practice and local labeling. Patients will be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

NCT ID: NCT02056548 Not yet recruiting - Lymphoma Clinical Trials

Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy

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

Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Based on the study results, guidelines recommend that preemptive antiviral therapy should be maintained for at least 6 months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or longer after final chemotherapy without definite evidences, and this practice increases the medical expenditure a lot. Therefore, the investigators are going to find out the proper and safe duration of preemptive antiviral therapy which can be a good reference in the future practice.

NCT ID: NCT01949168 Not yet recruiting - Chronic Hepatitis C Clinical Trials

A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV

HCV-6
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection. Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection. The investigators therefore hypothesise that: i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo. ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.

NCT ID: NCT01926860 Not yet recruiting - Clinical trials for Measurement of Immune Response to Prevenar13

PCV13 + Hepatitis A Vaccine for Adults

PCV13+HepA
Start date: September 2013
Phase: Phase 4
Study type: Interventional

The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.

NCT ID: NCT01835938 Not yet recruiting - Clinical trials for Chronic Hepatitis C Infection

Clinical Investigation of Erlotinib as an HCV Entry Inhibitor

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

Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. Current combination therapy of pegylated interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial side effects. The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants resistant to host immune responses. Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral approach for prevention and treatment of HCV infection (European patent application EP 08 305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature Medicine 2011). Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with HCV. Following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.

NCT ID: NCT01776814 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

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

Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.

NCT ID: NCT01750515 Not yet recruiting - Acupuncture Clinical Trials

Acupuncture as an Adjunctive Treatment for Hepatitis C Patients

Start date: January 2013
Phase: N/A
Study type: Interventional

Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin). Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline characteristics(17,18,19). Patients will be randomized into intervention and control groups, 30 patients each.In the Intervention group each patient will receive an acupuncture treatment once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be individualized for each patient according to TCM diagnosis. This treatment protocol is acceptable and has been published(20,21,22).In the control group patients will receive standard treatment alone, with no other intervention. Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) in order to detect changes from baseline and group differences. Inclusion criteria: adult patients with a confirmed HCV infection Exclusion criteria: Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1 year Study Location: "Ziv" medical center, division of liver disease, Israel

NCT ID: NCT01731301 Not yet recruiting - Clinical trials for End Stage Renal Disease

A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

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

1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. 3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

NCT ID: NCT01724723 Not yet recruiting - Tuberculosis Clinical Trials

Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment

HBV
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB patients, especially in those with viral hepatitis. A previous study revealed the risk of HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical study to assess the reduction of HATT risk by using entecavir in TB patients with high baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse events in two hospitals.