A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys...
Hepatitis CChronicThis open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib)...
PoliomyelitisTetanus5 moreThis study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus
Hepatitis B InfectionChronic Infection1 moreTo explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic...
Hepatitis BLiver TransplantationThe aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six and twelve months post-transplantation.
Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
Hepatitis BThis is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus...
Hepatitis C Virus (HCV)The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Hepatitis B InfectionChronic Infection1 moreImmunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients. Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL (or > 200,000 IU/mL) during late pregnancy and infants. Its efficacy in the reduction of HBV vertical transmission rate.
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric...
Chronic Hepatitis CThis is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.
Coffee Effect in HCV-related Hepatitis
Chronic HCV-related HepatitisBackground: In patients with chronic HCV-related liver damage, coffee is associated with a reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This prospective trial is aimed at assessing the mechanisms underlying the protective effect of coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with HCV-related hepatitis will be recruited and randomized into two groups: the first will consume 4 coffee cups/day/1 month, while the second will remain coffee "abstinent". At day 30, the two groups will be switched over and exposed to coffee or not for a second month. Before entering the study (time 0), during coffee exposure and during abstinence we will evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.
Patient-Centered Care and Asian Americans
Hepatitis BHepatitis C1 moreLiver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco. The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis. Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.