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Hepatitis clinical trials

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NCT ID: NCT02167113 Completed - Clinical trials for Hepatitis B, Chronic

Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay

HBVQuant
Start date: March 2014
Phase:
Study type: Observational

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.

NCT ID: NCT02166047 Completed - Chronic Hepatitis B Clinical Trials

Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants

Start date: June 30, 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).

NCT ID: NCT02165189 Completed - Hepatitits C Clinical Trials

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

GALAXY
Start date: August 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.

NCT ID: NCT02161952 Completed - Fibrosis Clinical Trials

Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Start date: May 2005
Phase: Phase 2
Study type: Interventional

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

NCT ID: NCT02161653 Completed - Clinical trials for Severe Alcoholic Hepatitis

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

NCT ID: NCT02161510 Completed - Hepatitis C Clinical Trials

Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The objective of this study is to identify a safe dose of MK-2248 in participants with Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from baseline. It is anticipated that once-daily administration of a safe and well tolerated dose of MK-2248 will reduce VL by at least 3 log10 IU/mL.

NCT ID: NCT02156570 Completed - Hepatitis C Clinical Trials

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)

DARE-C II
Start date: October 2014
Phase: Phase 4
Study type: Interventional

The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.

NCT ID: NCT02152709 Completed - Hepatitis B Clinical Trials

Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

NCT ID: NCT02139722 Completed - Hepatitis C Clinical Trials

Patient-Centered Care and Asian Americans

Start date: January 2, 2014
Phase: N/A
Study type: Interventional

Liver 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.

NCT ID: NCT02133131 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

Start date: June 13, 2014
Phase: Phase 2
Study type: Interventional

This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).