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Hepatitis clinical trials

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NCT ID: NCT02498275 Terminated - Clinical trials for Hepatitis B, Chronic

Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients

Start date: July 2014
Phase: N/A
Study type: Observational

This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.

NCT ID: NCT02498015 Completed - Clinical trials for Hepatitis C, Chronic

A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection

D3FEAT
Start date: August 2016
Phase: Phase 4
Study type: Interventional

A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.

NCT ID: NCT02496897 Completed - Hepatitis B Clinical Trials

Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B

Start date: July 2015
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.

NCT ID: NCT02496078 Completed - Hepatitis C Clinical Trials

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Start date: August 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

NCT ID: NCT02493855 Completed - Chronic Hepatitis C Clinical Trials

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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

To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

NCT ID: NCT02487199 Completed - Clinical trials for Hepatitis C Virus (HCV)

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

Start date: September 30, 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

NCT ID: NCT02487030 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Start date: September 7, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

NCT ID: NCT02486406 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

ZIRCON
Start date: October 28, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

NCT ID: NCT02485262 Recruiting - Hepatitis C Clinical Trials

Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience

Start date: November 2013
Phase: N/A
Study type: Observational [Patient Registry]

Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care (1-5). PR therapy offered limited performance and availability across the diverse spectrum of HCV disease and was fraught with excessive and often limiting side effects. The first direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could only be used only in combination with PR because of concerns for rapid PI viral resistance. Although the first generation PIs added increased efficacy to the PR regimen, they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes, disease stages, and special patient groups such as those co-infected with HIV. When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients yet can be given in a personalized regimen to maximize performance

NCT ID: NCT02485106 Not yet recruiting - Clinical trials for Severe Alcoholic Hepatitis

Rifaximin Use in Severe Alcoholic Hepatitis

Start date: July 2015
Phase: Phase 3
Study type: Interventional

This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.