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Hepatitis C Virus Infection clinical trials

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NCT ID: NCT06463912 Recruiting - Clinical trials for Hepatitis C Virus Infection

Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia

HCV-PIWD
Start date: May 20, 2024
Phase:
Study type: Observational

Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over 20 years. Despite undeniable advances in the treatment of hepatitis C infection and the WHO strategy to eliminate hepatitis C by 2030, this infection continues to be a major public health problem globally and many HCV-positive individuals are unaware of their HIV status. People who inject drugs (PWID) are at increased risk for HCV. Several studies have reported high HCV prevalence rates, especially among PWID. PWID are usually exposed to a higher risk of various infectious diseases, mainly due to their drug consumption behaviors and habits, in addition to the risks and harms associated with the respective routes of self-administration. Worldwide, there are around 11 million PWIDs and there are approximately 2.3 million coinfections between HIV and HCV worldwide, of which more than half (1.3 million) occur in PWID. The coexistence of these two health conditions leads to accelerate the progression of liver disease. The global prevalence of HCV in 2019 among PWID was 50.2%, which is equivalent to 5.6 million people who inject drugs and live with hepatitis C. PWID had been considered a difficult group to reach, manage, and treat because HCV treatment management in these individuals is challenging and they have a higher risk of reinfection and some past HCV treatment guidelines excluded PWIDs from consideration, citing concerns about adherence, increased susceptibility to side effects, and reinfection. However, there is now compelling evidence that HCV treatment is safe and effective among PWID. In Colombia, the prevalence of hepatitis C among PWID has been measured locally in some cities. In Bogotá, it went from 1.7% in 2002 to 6.7% in 2014. For 2021, the prevalence of hepatitis C was measured in Bogotá, Medellín, Santiago de Cali, the metropolitan area of Pereira, Dos Quebradas, Medellín, Cucuta, and Armenia. The results of prevalence of antibodies against hepatitis C were as follows: Cali with 80.2%, is the city with the highest reactivity, followed by Pereira and Dos Quebradas with 71.4%, Armenia with 69.6%, and Cucuta with 62.8%. We do not have recent data about the impact of intervention to reduce HVC transmission in those groups.

NCT ID: NCT06431945 Recruiting - Clinical trials for Hepatitis C Virus Infection

Early Detection of HCV in Injection Drug Users

EDVIP
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.

NCT ID: NCT06155006 Recruiting - Clinical trials for Hepatitis C Virus Infection

Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia

HCVLINKAGE
Start date: December 16, 2023
Phase:
Study type: Observational

Introduction: Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over a 20-year period. According to 2019 data from the World Health Organization there are 58 million people living with chronic hepatitis C infection. Three-quarters of those infected live in low- to middle-income countries, some of which lack budgets for screening, diagnosis and treatment campaigns. While good progress has been made in several countries, a significant gap in testing and treatment remains. Barriers to timely diagnosis include lack of awareness on the part of health professionals, availability and access to screening tests. Simplifying the cascade of care for this pathology would help ensure that more patients remain involved in the care pathway and ultimately achieve global goals. Objective: To estimate the prevalence of anti-HCV antibodies in patients with risk factors for hepatitis C virus captured by opportunity screening in the included hospital institutions. Methodology: Descriptive multicenter cross-sectional study. A total of 27160 participants among the seven institutions, 3880 per institution. Includes all persons over 18 years of age attended in the included health service provider institutions (IPS) who are users of hospitalization, emergency, outpatient and any other hospital care services. Application of a questionnaire to identify the inclusion criteria and data collection, signature of informed consent, sample collection by rapid test Abbott HCV rapid test - BIOLINE HCV and evaluation by tele-consultation by hepatologist principal investigator who will guide you to access the confirmatory test for HCV (viral load for Hepatitis C), the study will assume responsibility for its realization.

NCT ID: NCT05975216 Recruiting - Clinical trials for Hepatitis C Virus Infection

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Relink
Start date: July 6, 2023
Phase:
Study type: Observational

Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up. Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.

NCT ID: NCT05906459 Recruiting - Clinical trials for Hepatitis C Virus Infection

Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)

STAT
Start date: June 26, 2023
Phase:
Study type: Observational

The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.

NCT ID: NCT05363865 Recruiting - HIV Infections Clinical Trials

Digital Community to Improve Health in Rural Areas

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

The study is a cluster randomized controlled trial developed in counties located in Appalachia and the Midwest. We will prioritize counties from states with high risk for HIV and HCV infection associated with injection drug use.

NCT ID: NCT05092074 Recruiting - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection

Start date: October 1, 2021
Phase:
Study type: Observational

The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.

NCT ID: NCT04852614 Recruiting - Clinical trials for Hepatitis C Virus Infection

Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

Start date: December 1, 2020
Phase:
Study type: Observational

This is a prospective, observational, open-label, pharmacokinetic study will evaluate PK of SOF/DAC in lactating HCV-infected females at weaning or women who voluntarily decided to forego breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.

NCT ID: NCT04768517 Recruiting - Clinical trials for Hepatitis C Virus Infection

HCV Reinfection in in HIV/HCV-coinfected Patients Achieving SVR by Antiviral Therapy

Start date: February 9, 2021
Phase:
Study type: Observational

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO. Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients. Because data regarding to the HCV reinfection in HIV-positive patients are still limited, where a more comprehensive assessment of HCV reinfection is important based on the perspectives of HCV microelimination among HIV-positive patients in Taiwan, the investigators thus aim to conduct a long-term, large-scale cohort study to assess the risk of HCV reinfection in HIV-positive patients achieving SVR after IFN-based or IFN-free therapies, and to assess the factors associated with different risks of reinfection in these patients.

NCT ID: NCT04732832 Recruiting - Clinical trials for Hemodialysis Complication

HCV Reinfection in HD Patients Achieving SVR

Start date: February 1, 2021
Phase:
Study type: Observational

Among the hemodialysis units, the global incidence of HCV infection ranges from 1.2% to 2.9%. Data regarding the long-term risk of reinfection among hemodialysis patients achieving SVR are limited. To our best knowledge, only one study assessed the long-term negativity of serum HCV RNA in hemodialysis patients who achieved SVR after IFN-based therapies. With a median follow-up of 48 months following SVR, the life-time cumulative survival for HCV RNA negativity was 86% among the 121 participants who were on maintenance dialysis. Furthermore, the life-time cumulative survival for HCV RNA negativity was 95% among the 45 participants who underwent renal transplantation from HCV-negative donors. Because the literatures regarding the long-term follow-up of viral outcome, the patient numbers to be recruited are still limited, and all studies are focused on IFN-based treatment, we aim to assess the long-term risk of HCV reinfection in hemodialysis patients attaining SVR by IFN-based or IFN-free therapies.