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Hepatitis C Infection clinical trials

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NCT ID: NCT04042740 Completed - HIV Infection Clinical Trials

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection

PURGE-C
Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection.

NCT ID: NCT03122132 Completed - Clinical trials for Hepatitis C Infection

Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

3D8
Start date: February 20, 2017
Phase:
Study type: Observational

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

NCT ID: NCT02982993 Completed - Clinical trials for Hepatitis C Infection

Hepatitis C Infection in World Trade Center Responders

Start date: December 2016
Phase:
Study type: Observational

This study provides Hepatitis C virus screening to the members of the World Trade Center Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965, and linkage to care for those found infected. The study will also determine if exposure to human remains, blood and/or bodily fluids during the World Trade Center Health Program activities are associated with Hepatitis C virus infection. These findings would be relevant to the larger United States population, especially to persons born during 1945-1965 who are at high risk of Hepatitis C virus infection.

NCT ID: NCT02940496 Completed - Clinical trials for Hepatitis C Infection

Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer

Start date: December 9, 2016
Phase: Phase 2
Study type: Interventional

This phase I/II clinical trial studies the side effects of pembrolizumab with or without elbasvir/grazoprevir and ribavirin and to see how well they work in treating patients with liver cancer that has spread to other places in the body and does not respond to previous treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Elbasvir/grazoprevir and ribavirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab in combination with elbasvir/grazoprevir and ribavirin may work better in treating patients with liver cancer than with pembrolizumab alone.

NCT ID: NCT02582632 Completed - Hepatitis C Virus Clinical Trials

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

GARNET
Start date: November 24, 2015
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

NCT ID: NCT02568332 Completed - Clinical trials for Hepatitis C Infection

A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals

Start date: July 21, 2015
Phase: Phase 1
Study type: Interventional

This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.

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: NCT02362217 Completed - HIV Infection Clinical Trials

A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination

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

This study is aimed at assessing the safety of candidate Hepatitis C vaccines AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered separately or in combination to healthy volunteers. The study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.

NCT ID: NCT02323594 Completed - Clinical trials for Hepatitis C Infection

A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

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

Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet

NCT ID: NCT02247440 Completed - HIV Clinical Trials

HCV-HIV Co-infected Patient Cohort in Thailand

Start date: August 2014
Phase: Phase 4
Study type: Interventional

This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment. Chronic hepatitis C virus (HCV) infection is responsible for several severe and life threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV replication is suppressed on antiretroviral treatment. The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured are no longer contagious to other individuals, therefore widespread access to HCV treatment may contribute to the control of the HCV epidemic. A combination of injectable pegylated-interferon with oral ribavirin is currently the recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They are administered for 24 weeks in HCV mono-infected patients but need to be administered for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter treatment. PRIMARY OBJECTIVE 1. To determine the percentage of patients according to genotypes with sustained virological response 6 months after treatment discontinuation (SVR). HCV TREATMENT - Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week) - Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of anemia. A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a first part (starting in August 2014) and 45 patients in a second part, depending on funding.