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Hepatitis C clinical trials

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NCT ID: NCT06306300 Recruiting - Hepatitis C Clinical Trials

Randomized Open-label and Non-inferiority Clinical Trial

Start date: July 4, 2022
Phase: Phase 4
Study type: Interventional

Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study). The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS.

NCT ID: NCT06263829 Not yet recruiting - Hepatitis C Clinical Trials

HCV Tappt Adherence Study

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting. - The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates. - The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement. Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period. Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.

NCT ID: NCT06244966 Not yet recruiting - HIV Infections Clinical Trials

GUM Remote Testing v4.0

Start date: February 2024
Phase: N/A
Study type: Interventional

Capillary blood sample results are compared to venous blood results

NCT ID: NCT06203925 Not yet recruiting - Hepatitis C Clinical Trials

Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro

Start date: January 8, 2024
Phase:
Study type: Observational

Sexual and gender minorities (SGM), such as gay, bisexual and other men who have sex with men (MSM) and transgender women (TGW), are at high risk of HCV infection. A recently released guideline by the WHO recommended HCVST to scale-up HCV screening. However, data on delivery-services of HCVST kits and uptake of HCV testing using HCVST remain scarce in Latin American countries. Additionally, data on the usability of HCVST in MSM/TGW, especially blood-based tests, still lacking in Brazil. To evaluate the uptake of HCV testing by the strategy of using HCVST ordered by the internet and delivery by the post in key populations (SGM) living in the metropolitan region of Rio de Janeiro (Brazil). Additionally, an Ancillary study will assess the usability of different kits of HCVST in MSM/TGW using PrEP. Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study.Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study. Methods: For the Primary Study, a web-based platform will be built for this project and an educational campaign will be developed in dating apps to encourage HCV testing. The web platform will contain modules with information on HCV infection and a log-in to request HCV self-tests that can be delivered by the post or collected in the centralized pharmacy for HCV testing. People will be encouraged to report their HCVST results in the online platform. People with positive HCV antibody will be linked-to-care for HCV infection confirmation and treatment initiation. For the Ancillary Study, MSM/TGW attending presential visits for PrEP at INI/FIOCRUZ will be invited to perform HCVST (blood-based and oral fluid tests) under supervision of a trained healthcare worker. Participants will read written instructions and watch a video explaining the procedures step-by-step for HCVST. A second HCV test using the same kit will be performed by the healthcare worker for concordance analysis. People with positive HCV antibodies will be linked to HCV infection confirmation and treatment initiation. Data analysis: Descriptive statistical analysis will be used to evaluate the characteristics of people seeking HCVST, participant's preferences, uptake of HCV testing using self-test kits and internet technologies, as well as acceptability, usability and result interpretation of HCVST in a sub-sample of participants. Ethical considerations: Locally, ethics approval will be obtained from the INI/FIOCRUZ. International ethics clearance will be obtained from the World Health Organization Ethics Review Committee (WHO ERC). All participants will be informed of risks and benefits of the procedures and that their participation is voluntary. All participants will be required to sign the informed consent (an online agreement for Primary Study) as required by Brazilian regulations to participate in research studies. All data collected will respect The Brazilian General Data Protection Law (Law nº 13.709/2018).

NCT ID: NCT06180590 Recruiting - Chronic Hepatitis C Clinical Trials

The Efficacy of Vosevi in Treating DAA-experienced Patients

Start date: February 28, 2023
Phase:
Study type: Observational

Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas. Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis. After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin. In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows: A. To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients. B. To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy. C. To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy. D. To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.

NCT ID: NCT06179498 Recruiting - Hepatitis C Clinical Trials

Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).

NCT ID: NCT06159504 Not yet recruiting - Hepatitis C Clinical Trials

Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania

CUTTS HepC
Start date: March 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania. The main questions it aims to answer are: 1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries? 2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test? 3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody/confirmatory RNA test) model? Participants will: - be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2) - if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. - if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. Researchers will compare cure and participant retention rates between the two groups.

NCT ID: NCT06155006 Not yet 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 11, 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: NCT06104046 Not yet recruiting - Hepatitis C Virus Clinical Trials

Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis

Start date: October 26, 2023
Phase:
Study type: Observational

observational cross sectional study for children with chronic kidney disease who on regular hemodialysis in assiut univeristy children hospital at dialysis unit, observe prevalence of serological seroconversion of hepatitis c virus and associated risk factors

NCT ID: NCT06082336 Recruiting - Clinical trials for Combined Point of Care Diagnostic of HIV, HBV and HCV

Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C

MAGICIEN
Start date: January 23, 2023
Phase: N/A
Study type: Interventional

Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study. The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics)