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NCT ID: NCT06180590 Recruiting - Chronic Hepatitis C Clinical Trials

The Efficacy of Vosevi in Treating DAA-experienced Patients

Start date: February 28, 2023
Phase:
Study type: Observational

Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas. Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis. After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin. In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows: A. To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients. B. To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy. C. To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy. D. To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.

NCT ID: NCT05476705 Not yet recruiting - Clinical trials for Medication Administered in Error

Identifying Drug-related Problems at ED Triage (DRP-EDiT) V1

DRP-EDiT
Start date: April 2023
Phase:
Study type: Observational

Up to a third of patients who visit emergency departments (EDs) do so because they have an issue with medicines prescribed by their doctor or purchased over the counter. For example, some patients might experience side effects (e.g., sickness), whereas others may feel their prescribed medicine is not working and want an alternative. While some patients who visit EDs know they have a problem with their medication, some are not aware. Furthermore, drug-related problems (DRPs) may not be identified by ED triage systems which are used to sort patients' priority for treatment. The currently used system in the UK (Manchester Triage System) mentions drugs infrequently and does not support the identification of the most common DRPs. For this project, DRPs include medication errors, adverse drug events, and adverse drug reactions. This project aims to revise the triage system to support the discovery of patients' medication problems when they are triaged by a nurse upon arrival to the ED. After identification, problems with a patient's medication should be dealt with by the healthcare professional who is most appropriate to manage that particular issue. For example, a patient who has been prescribed a new medicine but already takes 20 medicines will likely benefit from a review by a pharmacist in the ED. This project will aim to support the management of patients who might benefit from care provided by pharmacists by providing them with this care. As well as ensuring medication problems are identified at triage, and that pharmacists are involved in helping to deal with those problems, this project will also try to understand how we can investigate how pharmacists actually make a difference to the care of ED patients. A multi-step approach (Stages A-F) is proposed to answer the question "How can patient DRPs be identified, triaged and managed in the ED?" In summary, the steps include: STAGE A, a systematic review and scoping survey; STAGE B, researcher visits to ED sites to shadow ED staff; STAGE C, Interviews with healthcare professionals (including those shadowed in STAGE B) to validate findings of site visits and explore topics in more depth; STAGE D, developing additional drug-related content for the Manchester Triage System; STAGE E, involving a panel of experts in a RAND appropriateness method to rate the content developed in STAGE D; STAGE F, testing the revised triage system for a future pilot study involving interviews with staff visited in STAGE B.

NCT ID: NCT04220918 Completed - Clinical trials for Medication Adherence

Taste of Medicines in Children

Start date: February 14, 2020
Phase:
Study type: Observational

Some but not all children will refuse to take medicine because of its taste, which can lead to substantial worsening of disease, antibiotic resistance, increased health care costs, and even death. The investigators are systematically assessing individual variation in the taste of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard of care treatment, to determine whether (1) genetic variation underlies differences in taste ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood of side effects and medication non-adherence.

NCT ID: NCT01349556 Withdrawn - Medication Reaction Clinical Trials

Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

Start date: May 2011
Phase: N/A
Study type: Interventional

This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib. Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash. Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.