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Hepatitis C clinical trials

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NCT ID: NCT04033887 Completed - Hepatitis C Clinical Trials

Evaluation Study of RDTs Detecting Antibodies Against HCV

Start date: September 21, 2018
Phase:
Study type: Observational

The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection.

NCT ID: NCT04019717 Completed - Hepatitis C Clinical Trials

Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.

NCT ID: NCT04008927 Completed - Drug Use Clinical Trials

A Community-based Intervention Among Active Drug Users in Montpellier

ICONE
Start date: September 18, 2020
Phase: N/A
Study type: Interventional

The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.

NCT ID: NCT03995485 Completed - Clinical trials for Hepatitis C, Chronic

KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

KW-136_III
Start date: June 7, 2017
Phase: Phase 3
Study type: Interventional

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension treatment-free follow-up period.

NCT ID: NCT03987503 Completed - Clinical trials for Hepatitis C, Chronic

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NOW
Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.

NCT ID: NCT03980301 Completed - Hepatitis C Clinical Trials

Screening Hepatitis Positive Women for Congenital Anomalies

Start date: October 11, 2018
Phase:
Study type: Observational

Hepatitis C virus is one of the virulent viruses

NCT ID: NCT03961828 Completed - Hepatitis C Clinical Trials

Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus

Start date: October 1, 2017
Phase: Phase 4
Study type: Interventional

Patients with transfusion dependent Beta Thalassemia suffer from a high incidence of Hepatitis C infection especially in developed countries as Egypt. In our patients we also found a high correlation between hepatitic C infection and Liver fibrosis. in this study we offer our patients treatment with Direct antiviral drugs and assessed the degree of fibrosis before and after treatment. We tested Hyalornic acid as a predictor of the degree of fibrosis before and after treatment.

NCT ID: NCT03939013 Completed - Hepatitis C Clinical Trials

Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)

CT2
Start date: January 30, 2019
Phase: N/A
Study type: Interventional

Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).

NCT ID: NCT03935906 Completed - Hepatitis C Clinical Trials

Reaching mEthadone Users Attending Community pHarmacies With HCV

REACH HCV
Start date: October 8, 2019
Phase: N/A
Study type: Interventional

Hepatitis C Virus (HCV) is a blood-borne virus that damages the liver and is a major public health threat globally. Most individuals infected with HCV are unaware of it and show no symptoms until presenting with incurable, fatal end-stage disease. In Scotland and Australia approximately 0.7% of the general population has chronic HCV with 0.4% in Wales, and they are at risk of developing cirrhosis and hepatocellular carcinoma. The clinical challenge is to identify those infected and bring them into treatment before the disease advances. The greatest risk factor for acquiring HCV in many countries is through injecting drug use. On the road to recovery from drug use, many will receive long-term opiate substitution therapy (OST), commonly with methadone or buprenorphine. Internationally, OST is routinely dispensed by a community pharmacist. HCV testing can be offered by GPs, drugs workers, drug agencies, social workers, community pharmacies and needle exchange sites. Once patients are diagnosed, they are referred to a hospital-based service to receive anti-HCV treatment. In this pathway, less than 10% of the OST population is tested per year, and cumulative rates of testing are less than 50% of those on OST. Highly effective Directly Acting Antiviral (DAA) treatment combinations are now available and achieve HCV cure rates in excess of 95%, with once or twice daily tablets for 8-24 weeks. The REACH HCV study will compare efficacy of an education-only HCV referral and treatment pathway against a nurse-led point-of-care device testing and treatment pathway among OST patients in community pharmacies in Scotland, Wales and Australia. Eligible participants will be treated using DAAs.

NCT ID: NCT03923595 Completed - Hepatitis C Clinical Trials

Puglia HCV Micro-elimination Program

PHCVM
Start date: July 30, 2019
Phase:
Study type: Observational

High rates of HCV infections occur in individuals with Substance Use Disorder (SUD), particularly in subjects with Alcohol Use Disorder and in People Who Inject Drugs (PWID), but also in subjects taking psychiatric medications. In our geographic area, HCV prevalence data are available for PWID only, with >25% of them infected with HCV. The best strategy to achieve micro-elimination is targeted active screening. In Italy, SERDs assess and manage SUD individuals, but are not allowed to treat patients. Moreover, they have limited resources to perform HCV screening and to ensure linkage to care for SUD individuals living in peripheral areas. Fifteen SERDs are present in Northern Puglia and Molise, a geographical area of about 7500 Km2 usually served by our Hepatology Unit. This geographic area is not very well served by public transport leading to a logistical barrier to access needed services delivered by our unit. This issue can negatively affect engagement with clinical services for viral hepatitis even in the era of DAA. Moreover, during treatment, it is not infrequent for patients to discontinue therapy due to a chaotic lifestyle, poor income conditions and the limited access to public transportation which is needed to adhere to on-treatment monitoring. Primary objective to plan and deliver a program of dedicated transportations and cure for patients with SUD and hepatitis C who live in peripheral areas of our region. It will translate in higher rates of screening, successful linkage to care, commencement and completion of DAA treatments leading to HCV microelimination. We plan to expand our collaborative work involving up to 15 SERDs form Northen of Puglia. The program consists of -peer to peer meetings with SERDs physicians and teams, educational campaigns for patients and screening of SUD individuals and their partners using oral Quick HCV test at each SERD, - dedicated transportation services, - complete virological and liver disease evaluation at our Hospital. This organization will guarantee direct connections between Hospital and patients included in the program. This program will ensure screening of patients with suspected infection at SERD, linkage to care of newly diagnosed subjects and completion of treatment for subjects who need to start DAA therapy. The rate of screening and successful linkage to care for each SUD subgroup will be characterized as well as the cascade to care.