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Hepatitis C, Chronic clinical trials

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NCT ID: NCT05895448 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded. Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.

NCT ID: NCT04136405 Active, not recruiting - Chronic Hepatitis c Clinical Trials

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

REVERSO
Start date: July 14, 2020
Phase:
Study type: Observational

This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

NCT ID: NCT04070235 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

Start date: March 29, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

NCT ID: NCT04039698 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment. The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

NCT ID: NCT04029246 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Re-engaging Patients With Hepatitis C Into Care

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Aims: To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care. Outcomes of interest: Primary outcome of interest: - Attendance for assessment of liver disease within 4 months of being sent invitation letter. Secondary outcomes of interest: - Commencing treatment within 6 months of being sent invitation letter. Methods: Patient identification: The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore. Inclusion criteria: Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success. Exclusion criteria: Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area. Allocation to contact groups: Patients will be randomly distributed into 3 groups: 1. Letter: Will be sent letter 1 (appendix) 2. Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks 3. Letter plus incentive: will be sent letter 3 (appendix) Process: Patient letters will be sent out by GG&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed". Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence. Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database. Lay Summary: This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.

NCT ID: NCT03993925 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong

Start date: September 20, 2019
Phase:
Study type: Observational

In the current era of highly effective direct acting antiviral (DAA) therapy, the remaining obstacles to elimination of chronic HCV infection are identification of the high-risk groups, linkage to continued care and prevention of re-infection. It is estimated that 70-80% of patients with chronic HCV are unaware of their infection. Besides, public health education is limited and most patients are not aware that the current standard-of-care is highly effective, well tolerated and no longer require weekly subcutaneous injections. From a survey in Hong Kong in 2014, among 234 newly diagnosed HCV patients, only 20% agreed to undergo treatment. There is no universal screening programme for chronic hepatitis C infection in Hong Kong. and known high-risk patients include people who inject drugs (PWID), persons with certain medical conditions including those on hemodialysis, HIV infected, those with prior transfusion or organ transplantation. In this study, the investigators plan to reach out to PWIDs, people with substance abuse or prison inmates to provide rapid point-of-care screening for chronic hepatitis C infection, and to provide linkage to care for those diagnosed with chronic hepatitis C.

NCT ID: NCT03459768 Active, not recruiting - Tuberculosis Clinical Trials

Cohort Study on People Who Inject Drugs in Senegal

CoDISEN
Start date: August 24, 2016
Phase:
Study type: Observational

The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar, Senegal.

NCT ID: NCT03164902 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence

DASH
Start date: July 21, 2017
Phase: N/A
Study type: Interventional

This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.

NCT ID: NCT03163849 Active, not recruiting - Chronic Hepatitis c Clinical Trials

Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients

Start date: September 1, 2019
Phase: Phase 3
Study type: Interventional

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

NCT ID: NCT03155906 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Integrated Treatment of Hepatitis C Virus Infection

INTRO-HCV
Start date: May 18, 2017
Phase: N/A
Study type: Interventional

INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST) compared to standard treatment. The trial will recruit approximately 250 HCV infected in Bergen and Stavanger and about 1000 in a linked observational study. Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and treatment evaluation and treatment delivery. Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger (intervention arm) with standard treatment provided after referral to infectious disease clinics among patients who receive OST having HCV Secondary objectives: Compare treatment adherence between the intervention and control arms, and assess changes in quality of life, fatigue and psychological well-being before and after HCV treatment, as well as changes in drug use, infection related risk behavior, and risk of reinfection among those with sustained virological response. Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study population: The target group will be patients receiving care with MAR from involved outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and eligible for treatment according to national guidelines. Study duration: Participants will be included and followed up at least annually for the total study duration between 2017 and 2021. Expected outcome: This study will inform on the relative advantages and disadvantages of an integrated treatment program for HCV into MAR compared to standard care aiming to increase access to treatment and improved treatment adherence. If the integrated treatment structure is found to be safe and efficacious, it can be considered for further scale-up.