Very Rapid and Rapid Virological Response as Predictors of Response of HCV Tretment

July 5, 2018 updated by: Sara Mohammed Mahrous Sayed, Assiut University

Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with HCV related liver disease ( either cirrhotic or non cirrhotic) eligible to tretment

Description

Inclusion Criteria:

  • Anti HCV positive patients either chronic HCV or liver cirrhosis.
  • Detectable HCV RNA by quantitative PCR prior to treatment.
  • Naïve patients (not received any HCV treatment regimen before)

Exclusion Criteria:

  • Patients with hepatocellular carcinoma( HCC)
  • Patients with combined HBV and HCV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)
Time Frame: April 2018 to April 2019
To assess rapid virological response as a predictor of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV. It measure the relation between rapid virological response and achievment of sustained virological response (Undetected HCV RNA 12-24 weeks after the end of treatment )
April 2018 to April 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HCV tretment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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