Active clinical trials for "Hepatitis"

Primary Efficacy Objective -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ] for 12 weeks (SVR12) after completion of the study treatment course Secondary Objectives To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12) To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC. To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12 Clinical hypotheses. Primary Efficacy Hypothesis - A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12. Secondary hypotheses A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12) Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations. In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12

This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.

Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum anti-viral therapy (AVT) is a advisable option to reduce mother-to-child transmission and the risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis. However, several controversies over antiviral treatment have not been resolved, that is, optimal duration, effect of postpartum therapy, and risk of postpartum alanine aminotransferase (ALT) flare after withdrawal. Will the risk of postpartum hepatitis flares increase after short-term AVT in late pregnancy for maternal HBV infection is discontinued? Is there any correlation between postpartum hepatitis flares and withdrawal time? Will the proportion of postpartum flares be reduced if extending the duration of AVT after delivery? There is an urgent need in this area. This study mainly investigated the safety of antiviral therapy in preventing HBV mother-to-child transmission in pregnant women after discontinuation.

This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in HIV-exposed infected infants. The primary objectives of the study are: To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants. To describe the persistence of all antibodies before receipt of the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants. To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants. The secondary objectives of the study are: To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants. To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants.

This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve. The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase. Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments: Arm A: Peg-IFN plus AL-3778 (N=20) Arm B: Peg-IFN plus matching placebo (N=10)

Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV) can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection. Whether patients with HCV infection have non-protective antibody responses to hepatitis B vaccination more frequently than healthy subjects is still controversial and studies about cytokine response have been seldom reported. Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender matched healthy control were obtained from a community-based screening. All participants received three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months schedule. Anti-HBs was tested 1 month after the third dose of vaccination and was compared between two groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.

Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the disease and the efficacy is seemingly not affected by a variety of viral factors. In addition, direct-acting antiviral agents therapy may affect the transformation of the immune cells and ameliorate the host immune status consequently. This study mainly investigated the relationship between Direct Acting Antiviral Treatment effect and the functional activity of myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic Hepatitis C.

Elimination of hepatitis C virus (HCV) is the process of stopping sustained transmission of viral hepatitis, reducing its incidence to zero and providing access to safe, affordable and effective treatment and care for everyone. Consequently, HCV will not be a leading cause of mortality (1). The World Health Organization (WHO) called for comprehensive programs that enhance access to affordable treatment in developing countries as HCV was considered a global public health priority since 2010 and set criteria of elimination(2). A disease is eliminated if its controlling efforts are sufficient to prevent an epidemic from occurring in a given geographical area and measures must be continued to prevent re-establishment of transmission (3) According to the Centers for Disease Control and Prevention (CDC), HCV now surpasses HIV as the nation's deadliest blood-borne disease. In addition, the majority of infected persons are not aware of their infection as they are not clinically ill and there is no vaccine for Hepatitis C. It is well known that the best way to prevent Hepatitis C is by avoiding behaviors that can spread the disease. (4) This study is a way forward for the elimination of hepatitis C from Egypt through applying different public health approaches for motivating people and changing villagers' risky behaviors aiming at increasing the number of people adopting healthy practices for decreasing the incidence rate of hepatitis in El Othmaneya village. The proposed activities along one year were applied for 3575 inhabitants aged more than 12 years who were get tested for Hepatitis C Virus (HCV) antibodies. The initiative activities were provided by community-led coalition and supported technically by the Egyptian Liver Research Institute and Hospital (ELRIAH).

In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.

Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.