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Hepatitis C clinical trials

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NCT ID: NCT05813691 Not yet recruiting - Hepatitis C Clinical Trials

Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

ERADIcATE
Start date: April 10, 2023
Phase:
Study type: Observational

The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy. The main questions it aims to answer are: what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up? Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.

NCT ID: NCT05769400 Not yet recruiting - Osteoporosis Clinical Trials

Awareness of Osteoporosis in Patients With Hepatitis C Infection

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hepatitis c virus infection are at increased risk for developing osteoporosis. Identifying whether patients with hepatitis c virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hepatitis c virus infection.

NCT ID: NCT05713136 Not yet recruiting - Hepatitis C Clinical Trials

The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

Start date: August 14, 2023
Phase:
Study type: Observational

This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to have HCV point-of-care testing. Participants who have not previously received HCV treatment will have a point-of-care HCV antibody test, followed by reflex point-of-care HCV RNA test if positive. Those who have a history of HCV treatment will proceed straight to point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will receive treatment via standard of care. The purpose of this study is to look at the effect of finger-stick point-of-care hepatitis C testing, to see if it increases the number of tests, diagnoses, and treatments for people with a risk factor of having hepatitis C in Australia.

NCT ID: NCT05692505 Not yet recruiting - HIV Infections Clinical Trials

Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Start date: April 1, 2023
Phase:
Study type: Observational

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

NCT ID: NCT05649202 Not yet recruiting - Clinical trials for Chronic HIV Infection

Hepatitis C in Prison: Study of Screening and Rapid Treatment (HEPAPRIS)

HEPAPRIS
Start date: January 2023
Phase:
Study type: Observational

Due to the high prevalence of HCV in prison and the risk of transmission between inmates, the management of hepatitis C and its treatment must be optimal following the recommendations of AFEF. The purpose of this study is to assess the treatment starting delay from the date of incarceration of inmates with chronic HCV infection (hepatitis C).

NCT ID: NCT05601518 Not yet recruiting - Clinical trials for Hepatitis C Infection

Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.

Start date: November 1, 2022
Phase:
Study type: Observational

Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients. The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide. Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets: Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%). Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.

NCT ID: NCT05506475 Not yet recruiting - HIV Infection Clinical Trials

Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam

MOVIDA-Hep2
Start date: May 2024
Phase:
Study type: Observational

With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be addressed. In remote settings, absence of HCV VL testing to identify those who require DAA and to monitor DAA success is a first issue. As of today, HCV VL testing is still restricted to central facilities in major cities. Blood sampling using DBS is an appealing option to allow HCV VL monitoring in remote settings as this option is inexpensive, does not require a cold chain for storage and transportation of the samples and can be implemented rapidly. A second issue is DAA access that remains scarce due to logistical and financial limitations. However, more affordable generic DAA, some of them being WHO pre-qualified, are now available. Vietnam is amongst the 20 countries with the highest HCV burden with an estimate of 1.5 million chronic HCV-infected people (HCV prevalence: 1.1%). As observed in many other settings, HCV prevalence is higher among vulnerable populations such as HIV-infected individuals and people who inject drugs (PWID). Vietnam has the will to increase access to DAA in the whole country. However, in remote settings, only some clinical sites will be allowed to dispense DAA. Discussions with the MoH of Vietnam brought to our knowledge that not all clinical sites caring for HIV patients and providing ART will dispense DAA. Thus, some HIV-HCV co-infected patients will be followed in clinical sites where they will receive both antiretroviral therapy and DAA, while some other patients will continue to be followed for HIV in their usual clinical site but will be asked to visit another clinical site for HCV care and to receive DAA. We anticipate that the proportion of patients who will comply with the 12-week DAA will be lower in patients followed for HIV and HCV in two clinical sites than in those followed in a single clinical site.

NCT ID: NCT05503979 Not yet recruiting - Clinical trials for Hepatitis C in Substance Users

Elimination of Hepatitis C Virus Among Users of Substances

EHCUS
Start date: November 15, 2022
Phase:
Study type: Observational

Substance users are a vulnerable group that should be prioritized in HCV (Hepatitis C Virus) elimination efforts in Mexico and in which it is feasible to carry out micro-elimination programs. It is an important group to treat both because of its high prevalence and because of the dynamic spread of infection among the general population. HCV seropositivity has not been documented in this group of people in Mexico City, the metropolitan area and the northern states of the country, nor has the sustained viral response been evaluated in this group of patients in the Mexican population.

NCT ID: NCT05467826 Not yet recruiting - Hepatitis C Clinical Trials

Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis

Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis. Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.

NCT ID: NCT05390424 Not yet recruiting - Hepatitis C Clinical Trials

Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

BUVARD
Start date: June 2022
Phase: N/A
Study type: Interventional

The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users