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Hepatitis clinical trials

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NCT ID: NCT03231605 Enrolling by invitation - Hepatitis A Clinical Trials

Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Start date: July 26, 2017
Phase: Phase 4
Study type: Interventional

Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.

NCT ID: NCT03018353 Enrolling by invitation - Clinical trials for Hepatitis C, Chronic

Curing HCV in Incarcerated Patients

CHIP
Start date: March 5, 2017
Phase: Phase 4
Study type: Interventional

Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).

NCT ID: NCT02699736 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

EuroSIDA
Start date: January 1994
Phase:
Study type: Observational [Patient Registry]

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.

NCT ID: NCT02588560 Enrolling by invitation - Lymphoma Clinical Trials

Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy

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

In last few years, most researches about hepatic complication after chemotherapy focused on hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are traditionally considered as relative safe to receive chemotherapy. However, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association of hepatitis are still unclear. Some epidemiologic studies demonstrated an association between HCV infection and B-cell lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area of HCV but there are limited reports addressing the clinical characteristics and prognosis in this unique population. Therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected lymphoma patients treated with chemotherapy.

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: NCT02419625 Enrolling by invitation - Chronic Hepatitis E Clinical Trials

The Epidemiology of Hepatitis E Virus Infection in Israel and Potential Risk Factors

Start date: June 2015
Phase: N/A
Study type: Interventional

Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately 7.2kb in length. The HEV genome is capped at the 5' end followed by a small untranslated region of 27 nucleotides and polyadenalated at the 3' end preceded by another UTR of 65 nucleotides . HEV has three open reading frames: ORF1, ORF2 and ORF3 that encode structural and non- structural proteins. ORF1 is the largest one, approximately 5,000 nt in length, located at the 5 ' end and encodes important proteins for the replication process (methyltransferase, papain-like cysteine protease, helicase, and RNA-dependent RNA polymerase). A noncoding, hypervariable region within ORF1 displays substantial genetic diversity; this region seems to modulate the efficiency of HEV replication. Notably, the differences in the genome size among different HEV strains are confined mainly to this region .ORF2 is located at the 3' end, encodes structural capsid proteins of 660 amino acids and contains three potential glycosylation sites. The ORF2 protein contains multiple immunogenic sites and neutralizing antibodies are directed against it al., .The essential region in the protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have recently been shown to be conformational .ORF3 is located between the other two reading frames and encodes a small phosphoprotein of 123 amino acids. Its exact function has not been yet determined, however, multiple functions have been proposed. It is thought to interact with cellular mitogen-activated protein kinase phosphatase and other extracellular kinases, promoting cell survival through activation of intracellular signaling pathways .Moreover, the binding of the ORF3 encoded protein to host-specific proteins seems to influence the pathogenesis of HEV infections .A schematic drawing of the HEV genome is described in Figure 1 .

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: NCT02116556 Enrolling by invitation - Alcoholic Hepatitis Clinical Trials

Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

RIFA-AAH
Start date: April 2013
Phase: Phase 2
Study type: Interventional

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis. The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

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: NCT01717560 Enrolling by invitation - Chronic Hepatitis C Clinical Trials

Hepatitis C Treatment in Underserved Populations

Start date: February 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.