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117 active trials for Hepatitis C

Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

Start: November 2018

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Start: February 2019

Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis

To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.

Start: July 2018

Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

Start: June 2021

Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study

Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.

Start: July 2019

A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt

Hepatitis C virus (HCV) is the major cause of chronic liver disease and has a long-term resultant complications4 and it considered as a major endemic medical health problem in Egypt. It affects multiple organs and reflect various manifestations on oral cavity.The purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral manifestation and gingival lesions in patients with hepatitis C

Start: March 2021

ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings

The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for subsequent establishment of HCV screening and treatment programs in drug treatment clinics and NSPs across NSW and nationally.

Start: May 2018

Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants

The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with HCV who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from the New York City (NYC) jails or New York State (NYS) prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.

Start: February 2021

Prisons Evaluation of a One-stop-shop InterVentiOn

An interventional cohort study will be used to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, same-visit direct-acting antiviral (DAA) prescription, and linkage to hepatitis care, on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.

Start: October 2019

Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons

Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks per week.

Start: January 2015

TeleHepC Treatment Trial

The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).

Start: June 2020

Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD

The objective of this study is to investigate the evidence of dopaminergic toxicity causing by HCV infection using 18F-FDOPA PET and MRS as imaging biomarkers.

Start: June 2017

Way to Cure HCV Adherence

This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.

Start: June 2015

Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants

The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan Africa have substantially higher prevalence than the general population and are consequently at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but current estimates put the number at around 50,000 due to primary refugee arrivals as well as secondary immigration from other states. There is no available data for Somali immigrants in the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development of HCC. Therefore. this study will fill these gaps in the Somali population to understand the relative importance of HBV and HCV infections in causation of HCC. Besides Somalis, Minnesota is also home to large other African immigrant communities. According to the Minnesota Department of Health (MDH), in 2013, the highest rates of chronic HBV cases where reported among Asian or Pacific Islanders (3,638 cases per 100,000 persons) followed by Black or African Americans (2,078 cases per 100,000 persons). Additionally, Minnesota receives a large number of new refugee's resettlement. It is important to improve the identification of chronic HBV and HCV infections among Somali refugees and immigrants in Minnesota through well-designed community-wide screening efforts. Since we know that African immigration to Minnesota is the third highest in the US, this unique population might be a contributing factor to the increased burden of hepatitis and liver cancer complications in the state of Minnesota. Findings from HBV and HCV screening among Somalis suggest that other immigrant African populations from high viral hepatitis endemic regions, such Ethiopia, Liberia, and Kenya, are also at substantial risk of HBV, HCV and HCC. Unfortunately, very little research has been conducted in the US on the burden of hepatitis and liver cancer in African Immigrants from areas of high endemicity of hepatitis B and hepatitis C. Therefore, the goal of is to identify HBV and HCV and the role viral genetics and immune response among African immigrant communities from Kenya, Liberia, and Ethiopia.

Start: November 2010

Community Access, Retention in Care, and Engagement for Hepatitis C Treatment

The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions 600 patients will be equally distributed into three study arms representing 3 care models: Arm 1: Current Care Model (management with current interdisciplinary team); Arm 2: PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); and Arm 3: Modified ECHO Model (management with expanded team in collaboration with community providers). An additional Arm 4 was started January 2021 to follow subjects experience with HCV management and treatment via telemedicine.

Start: August 2018

Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3

The goal of this study is to effectively use a client-centered community-based intervention to engage people who inject drugs (PWIDs) in healthcare that helps reduce risky behaviors and lower infectious disease risks. Participants in the intervention group of this study will undergo a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices geared towards reducing human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office will help coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades. PNs will also engage participants in HIV, HCV, and sexually transmitted infections(STIs) care cascades.

Start: March 2020

Prevention Support for People Leaving Jail

This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.

Start: November 2019

A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams

TEMPO is an interventional cohort study recruiting injecting drug users attending needle and syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site HCV testing with NSP integrated care for HCV treatment. Participants will be screened for HCV using point-of-care testing and HCV positive participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate treatment, participants will receive weekly peer-based support on-treatment and return at End of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.

Start: September 2019

Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs

This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle syringe (NSP) or needle exchanges (NEX) program services in Australia and New Zealand, to see if it can improve the number of people who start treatment following an HCV diagnosis: HCV testing from collected dried blood spots sent to a central laboratory HCV testing using a point-of-care device at the NSP/NEX site HCV testing using standard of care at the NSP/NEX site

Start: May 2021

Safety, Tolerability and Anti-tumour Activity Study of MTL-CEBPA Plus Sorafenib

This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) caused by a hepatitis B and/or C infection. Participants will be dosed with a combination of MTL-CEBPA (an experimental treatment) and sorafenib. The MTL-CEBPA is administered once a week via intravenous infusion for three consecutive weeks followed by a week of rest (one cycle). Sorafenib is taken orally from Day 8 at a dose of 400 mg twice a day. Participants will receive cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or death occurs.This combination of treatment was tested in a previous Phase I study (OUTREACH) which showed anti-tumour activity along with a good safety and toxicity profile.

Start: May 2021