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Hepatitis C clinical trials

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NCT ID: NCT03513796 Completed - Clinical trials for Hepatitis C, Chronic

Evaluation of Multiple HCV Diagnosis Pathways for Efficacy, Cost Effectiveness and Cure in NHS Tayside

Start date: June 20, 2018
Phase:
Study type: Observational

EVERYONES HCV is a retrospective review of all previous Hepatitis C (HCV) testing and diagnosis in NHS Tayside. The aim of this study is to analyse and compare the different Hepatitis C diagnostic pathways with a view to determining the most cost effective combination of methods of diagnosing HCV infection in a typical developed world population.

NCT ID: NCT03513393 Completed - Hepatitis C Clinical Trials

Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.

COPA
Start date: August 1, 2018
Phase: Phase 1
Study type: Interventional

Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.

NCT ID: NCT03512210 Completed - Hepatitis C Clinical Trials

Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

MINMON
Start date: October 22, 2018
Phase: Phase 4
Study type: Interventional

To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.

NCT ID: NCT03501550 Completed - Chronic Hepatitis C Clinical Trials

Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)

Start date: June 26, 2018
Phase: Phase 2
Study type: Interventional

Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection

NCT ID: NCT03492112 Completed - Hepatitis C Clinical Trials

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

TEMPO
Start date: September 10, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03490097 Completed - Metabolic Syndrome Clinical Trials

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Start date: December 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination

NCT ID: NCT03487107 Completed - Clinical trials for Chronic HCV Infection

Phase 3 Study of Yimitasvir Phosphate Capsules

Start date: April 17, 2018
Phase: Phase 3
Study type: Interventional

The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection.

NCT ID: NCT03485846 Completed - Clinical trials for Chronic Hepatitis C Genotype 1b

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b

Start date: November 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.

NCT ID: NCT03483818 Completed - Hepatitis C Clinical Trials

Pilot Trial of Directly Observed Anti HCV Therapy & Contingency Management in a Population on Opiate Substitute Therapy

DOT-C
Start date: November 2015
Phase: N/A
Study type: Interventional

DOT-C is a cluster randomised trial of a pharmacist-led, directly observed anti HCV therapy pathway versus the conventional care pathway within community pharmacies. The primary trial outcome is to evaluate the effect of pharmacist-led anti-HCV directly observed therapy on the proportion of patients reaching a sustained virological response.

NCT ID: NCT03482388 Completed - Hepatitis C Clinical Trials

Crowdsourcing to Promote HBV and HCV Testing in China

Start date: May 9, 2018
Phase: N/A
Study type: Interventional

This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.