Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1
Hepatitis CThis study is for people who have been diagnosed with chronic hepatitis C, specifically those who have a certain type of the virus, genotype 1, and who have not yet received treatment for hepatitis C. This pilot study is designed to test whether the addition of vitamin D, to the three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and ribavirin) that are approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C, can help eliminate the HCV from the body. Currently, doctors are unsure if the addition of vitamin D to prescribed hepatitis C therapy will have any effects on how the body clears the virus. Once enrolled, participants will be randomly assigned (like flipping a coin) to receive telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir + peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 - 20 participants/site). Participants assigned to the treatment group will begin a lead-in phase where they will receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase, participants will be tested to determine the Vitamin D level in their blood, as well as other tests, including HCV RNA (to determine the amount of virus present) and calcium levels. Once an adequate level of Vitamin D is detected in participants' blood, participants will begin treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (15,000 IU/week) for 12 weeks. Participants randomized to the control group will immediately begin treatment with telaprevir + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the participants' involvement in the study will be complete. Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at Screening, Day 1, Week 2, 4, 8 and 12.
A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)...
Hepatitis EThis phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or a 0-1-6 month schedule.
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune...
HepatitisAutoimmuneAn open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis...
Hepatitis EThis phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B VaccineIntramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.
Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients
Hepatitis AHuman Immunodeficiency Virus1 moreThough HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) have a higher risk of acquiring HAV due to their behaviors. Reemerging threat of hepatitis A among MSM in Taiwan has been reported recently. Based on the guidelines for the diagnosis and treatment of HIV/AIDS and the Advisory Committee on Immunization Practices (ACIP), Taiwan, vaccination of individuals against HAV with any of the following indications is recommended: HIV patients, adults with chronic hepatic disease, hemophilia, liver transplantation, occupational exposure, MSM, persons who use injection or noninjection illicit drugs, or persons traveling to or working in countries that have endemicity of HAV. In HIV-infected patients, the immunogenicity to HAV vaccination is sub-optimal in HIV-infected patients and the seroconversion rate is estimated 68-90% after administration of 2 or 3 doses of HAV vaccine. Furthermore, the antibody titers of HIV-infected patients following HAV vaccination are significantly lower compared to those of HIV-uninfected persons. The sub-optimal response among HIV-infected subjects remains an unresolved problem. In this study, the investigators aim to determine the to conduct a randomized clinical trial to compare the immunogenicity of 2 different doses of HAV vaccination (1 dose versus 2 doses) in HIV-infected patients who failed to achieve serologic response in the primary vaccination. This proposal will provide the solid evidence to elucidate the role of booster HAV vaccination in HIV-infected patients without response to primary HAV vaccination.
Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh....
Hepatitis E InfectionThe aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in women of child bearing age in preventing HEV disease during pregnancy among women in rural Bangladesh.
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis...
Chronic Hepatitis C VirusThe purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.
Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts
Hepatitis BThis study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.
Hepatitis B Vaccination in HIV-infected Adults
Hepatitis BThis is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.