Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs

February 9, 2020 updated by: Hossam eldeen Esmael Zayan, Assiut University
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).

The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .

To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy

Study Type

Observational

Enrollment (Anticipated)

50

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

11 months to 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with hepatitis C related liver cirrhosis being treatedusing the Egyptian National Guidelines will be enrolled. According to the most updated treatment protocol, patients undergo therapy for a relatively short period (3 to6 months).

Description

Inclusion Criteria:

  • Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
  • Age 18 years or older
  • Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
  • Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.

Exclusion Criteria:

  • Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
  • Coinfection with other viruses as HBV, HIV.
  • Had significant psychiatric illnesses (diagnosed by psychiatrist)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
Time Frame: one year
evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
one year

Collaborators and Investigators

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

Sponsor

Assiut University

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)

February 1, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 9, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • life quality with DAAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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