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Hepatitis C, Chronic clinical trials

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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: 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: NCT04014179 Recruiting - Hepatitis C Clinical Trials

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

TEMPO
Start date: July 27, 2022
Phase: N/A
Study type: Interventional

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 and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis: 1. HCV testing from collected dried blood spots sent to a central laboratory 2. HCV testing using a point-of-care device at the NSP site 3. HCV testing using standard of care at the NSP site

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: 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: 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: NCT03941821 Not yet recruiting - Chronic Hepatitis c Clinical Trials

Glecaprevir/Pibrentasvir Real-world Study in China

Start date: June 30, 2019
Phase:
Study type: Observational

To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study

NCT ID: NCT03903185 Completed - Clinical trials for Hepatitis C, Chronic

Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

Start date: March 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy. In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.

NCT ID: NCT03903081 Completed - Chronic Hepatitis C Clinical Trials

The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

HEC110114
Start date: March 6, 2019
Phase: Phase 1
Study type: Interventional

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

NCT ID: NCT03896087 Completed - Clinical trials for Hepatitis C, Chronic

Evaluation of Dried Blood Spot for HCV RNA Testing

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

FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).