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

HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03897608
• Other study ID #: life quality with DAAD
• Status: Not yet recruiting
• Start date: February 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2020
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 11 Months to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs
• Liver Cirrhosis

Intervention

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"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

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