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Hepatitis C clinical trials

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NCT ID: NCT02452814 Completed - HCV Clinical Trials

Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Start date: May 7, 2014
Phase: N/A
Study type: Observational

Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection

NCT ID: NCT02446717 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

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

The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

NCT ID: NCT02442284 Completed - Cirrhosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

Start date: May 13, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

NCT ID: NCT02442271 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

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

This is a Phase 3b, open-label, multicenter study to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12), in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.

NCT ID: NCT02441283 Completed - Hepatitis C Clinical Trials

A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Start date: June 22, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

NCT ID: NCT02439567 Completed - Cirrhosis Clinical Trials

Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)

SPLEEN-C
Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.

NCT ID: NCT02427204 Completed - Clinical trials for Hepatitis C Infection

Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality

Start date: June 2015
Phase:
Study type: Observational

The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.

NCT ID: NCT02421211 Completed - Clinical trials for Hepatitis C, Chronic

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Start date: May 19, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.

NCT ID: NCT02413593 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

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

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

NCT ID: NCT02405013 Completed - Hepatitis C Clinical Trials

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

TAC
Start date: October 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa Secondary Objectives: 1. To estimate the study treatment SVR24 rate 2. To evaluate the clinical and biological tolerance of study treatment 3. To describe HCV kinetics under HCV treatment, and identify associated factors 4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients 5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24 6. To identify factors associated with SVR12 and SVR24 (including HIV status) 7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24) 8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon 9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.