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Hepatitis C, Chronic clinical trials

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NCT ID: NCT02470858 Completed - Clinical trials for Chronic Hepatitis C Infection

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

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

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

NCT ID: NCT02468648 Completed - Chronic Hepatitis C Clinical Trials

Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Start date: June 9, 2015
Phase: Phase 2
Study type: Interventional

Background: - Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: - To learn why new hepatitis C drugs sometimes do not work. Also, to learn if these drugs are safe and how well they work in people with different virus strains. Eligibility: - Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus. Design: - Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires. - Participants will have a Fibroscan, an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram. - Eligible participants will have a liver biopsy. - Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires. - They will take the first study drug dose as a tablet taken once daily. - Participants will take the drug at home for 12 weeks. - Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires. - At week 4, participants will have another liver biopsy. - After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.

NCT ID: NCT02461745 Completed - Clinical trials for Hepatitis C, Chronic

Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO

Start date: June 2015
Phase: Phase 4
Study type: Interventional

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

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: NCT02439918 Completed - HIV Clinical Trials

Epidemic History and Iatrogenic Transmission of Blood-borne Viruses in Mid-20th Century Kinshasa

Start date: June 2012
Phase: N/A
Study type: Observational

Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1 (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1 epidemic remain unclear; mounting evidence suggests medical interventions may have contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are viruses compatible with long-term survival but with broadly similar modes of transmission as HIV. The main objective was to assess the association of past intravenous treatment with HCV and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the mid-20th century may have facilitated the emergence of HIV-1 in central Africa. To assess the association of injectable treatments with HCV and HTLV-1 infection and to reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839 elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods were used to reconstruct the epidemic history of HCV.

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: 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.