Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03480269
Brief Summary:
assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.
Detailed Description:
Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history
. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy
Treatment response terms:
The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.
The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.
The rapid virological response (RVR) defined as undetectable serum HCV RNA after 4 weeks of treatment sustained virological response (SVR), which is defined by the undetectable serum HCV RNA 12-24 weeks after the end of treatment Relapser was defined as undetectable viral load at the end of DAA treatment but subsequent detectable viral load at 12 weeks after treatment end.
Study:
NCT03480269
Study Brief:
Protocol Section:
NCT03480269