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Hepatitis C, Chronic clinical trials

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NCT ID: NCT03149289 Completed - Clinical trials for Hepatitis C, Chronic

Hepatitis C Virus Infection in Patients With Hemoglobinopathies

Start date: March 1, 2015
Phase: N/A
Study type: Observational

Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. However, data regarding the use of direct-acting antiviral drugs (DAAs) in this patient population are very few This large, observational study evaluated the safety and efficacy of standard therapy with DAAs in a large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver fibrosis.

NCT ID: NCT03144440 Completed - Hepatitis C Clinical Trials

Real World Experience of Chronic Hepatitis C (CHC) Treatment in Israel

Start date: December 13, 2016
Phase:
Study type: Observational

Primary objective: 1. To estimate the effectiveness of treatment with FDC of Zepatier with or without ribavirin in Israeli patients with CHC and advanced fibrosis in real life setting. Secondary objective: 1. To estimate the safety and tolerability of treatment with FDC of Zepatier with or without ribavirin in real life setting in Israeli patients with CHC and advanced disease. Hypotheses: Effectiveness and tolerability of treatment with FDC of Zepatier with or without ribavirin in Israeli patients with CHC and advanced fibrosis will be similar to that demonstrated in phase 3 clinical trials.

NCT ID: NCT03119025 Completed - Clinical trials for Hepatitis C, Chronic

Autologous Dendritic Cell Vaccine for Treatment of Patients With Chronic HCV-Infection

Start date: May 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Clearance of HCV infection requires early and multi-specific HLA class I restricted CD8+ T cell and class II restricted CD4+ T cell responses to both structural (Core) and non-structural HCV proteins (NS3, NS4A, NS5A, NS5B). Dendritic cells (DCs) are professional antigen-presenting cells that link innate and adaptive immune responses, and play a major role in priming, initiating, and sustaining strong anti-HCV T cell immune responses. The general objective of this study is to evaluate safety, feasibility and clinical efficacy of therapeutic vaccination in genotype 1 HCV patients using autologous DCs pulsed with recombinant HCV-antigens (Core and NS3). Expected effects: DC vaccination induces Core/NS3-specific immune response and reduces viral load in patients with chronic HCV-infection.

NCT ID: NCT03117569 Completed - Clinical trials for Hepatitis C, Chronic

Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients

SMART-C
Start date: August 21, 2017
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification. Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks. One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).

NCT ID: NCT03098121 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

Start date: October 20, 2017
Phase: Phase 4
Study type: Interventional

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

NCT ID: NCT03090035 Completed - Hepatitis C Clinical Trials

Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses Chronic Hepatitis C Treatment

Start date: January 1, 2014
Phase: Phase 3
Study type: Interventional

Objective: Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection. This study was conducted to find out the frequency of different IL-28B (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 & 3) infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response (SVR). Methods: In this non-randomized observational study, ninety eight (98) patients with diagnosis of chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in standard doses for 24 weeks. End treatment response, sustained virological response, and relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860) polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.

NCT ID: NCT03089944 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

EXPEDITION-8
Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

NCT ID: NCT03088917 Completed - Chronic Hepatitis c Clinical Trials

'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Track&Trace
Start date: September 27, 2017
Phase:
Study type: Observational

Objective: To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options. Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.

NCT ID: NCT03074331 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Start date: March 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.

NCT ID: NCT03069365 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment

EXPEDITION-5
Start date: March 28, 2017
Phase: Phase 3
Study type: Interventional

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.