An observational study in HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs, sponsored by Assiut University. Status unknown. Open to participants aged 11 Months to 12 Months. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Assiut University · Observational
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
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
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 50 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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).
Exclusion Criteria:
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"
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
Time frame: one year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Assiut University