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Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial

NCT04330508 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 385

Last updated 2024-02-13

No results posted yet for this study

Summary

Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.

Conditions

  • Depression in Chronic Hepatitis C

Interventions

OTHER

Depression and Cognitive Tests

Health Related Quality of Life, neurocognitive tests, PHES

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Madhumita Premkumar, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04330508 on ClinicalTrials.gov