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Hepatitis clinical trials

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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: NCT02417597 Completed - Hepatitis E Clinical Trials

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

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

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

NCT ID: NCT02417207 Not yet recruiting - Hepatitis B Clinical Trials

Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation

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

The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.

NCT ID: NCT02413593 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

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

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

NCT ID: NCT02412592 Recruiting - Chronic Hepatitis B Clinical Trials

Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy

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

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

NCT ID: NCT02412319 Active, not recruiting - Clinical trials for HBeAg Positive Chronic Hepatitis B

The Clinical Trial of the Anti Hepatitis B Placenta Transfer Factor Injection

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.

NCT ID: NCT02405013 Completed - Hepatitis C Clinical Trials

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

TAC
Start date: October 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa Secondary Objectives: 1. To estimate the study treatment SVR24 rate 2. To evaluate the clinical and biological tolerance of study treatment 3. To describe HCV kinetics under HCV treatment, and identify associated factors 4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients 5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24 6. To identify factors associated with SVR12 and SVR24 (including HIV status) 7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24) 8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon 9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.

NCT ID: NCT02404805 Completed - HIV Clinical Trials

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

Start date: February 2016
Phase: N/A
Study type: Interventional

The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.

NCT ID: NCT02404636 Active, not recruiting - Clinical trials for Hepatitis, Alcoholic

Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

ADDUP
Start date: January 2012
Phase: N/A
Study type: Observational

ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate: 1. Alcohol use 2. Dietary intake 3. Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival. The study is intended to explore potential precipitants of alcoholic hepatitis.

NCT ID: NCT02402699 Completed - Hepatitis C Clinical Trials

Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Yervoy RMP
Start date: December 15, 2015
Phase:
Study type: Observational [Patient Registry]

This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.