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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03897608
Collaborator
(none)
50
Enrollment
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Condition or Disease Intervention/Treatment Phase
  • Behavioral: short form 36

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs [one year]

    evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Months to 12 Months
Sexes Eligible for Study:
All
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
    1. auto immune liver disease, PBC

  • Coinfection with other viruses as HBV, HIV.

  • Had significant psychiatric illnesses (diagnosed by psychiatrist)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hossam eldeen Esmael Zayan, RESIDENT DOCTOR, Assiut University
ClinicalTrials.gov Identifier:
NCT03897608
Other Study ID Numbers:
  • life quality with DAAD
First Posted:
Apr 1, 2019
Last Update Posted:
Feb 11, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis

Study Results

No Results Posted as of Feb 11, 2020