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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03897608
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Information provided by (Responsible Party):
Hossam eldeen Esmael Zayan, Assiut University

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
HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs 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

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Intervention Details:
  • Behavioral: short form 36
    The Short Form (SF)-36 Health Survey was used to measure HRQL. The SF-36 generates a profile of HRQL outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0to100; where100 indicates "good health"

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Months to 12 Months   (Child)
Sexes 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).

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)

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Responsible Party: Hossam eldeen Esmael Zayan, RESIDENT DOCTOR, Assiut University Identifier: NCT03897608     History of Changes
Other Study ID Numbers: life quality with DAAD
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Antiviral Agents
Anti-Infective Agents