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

February 12, 2024 updated by: Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

Effects of Direct-acting Antiviral Agents on Cognitive Function, and Depression in Chronic Hepatitis C

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigations will be performed according to the Declaration of Helsinki and approval of the enrolment as well as the usage of patient blood samples for research purpose will be obtained from the institutional ethics committee, and written informed consent will be obtained from all patients.The primary analysis upon which the sample size consideration was based involved the comparison of the SVR subgroup and the subgroup of patients without SVR. For the sample size calculation, we a two-factorial design (time course × SVR) with the use of a two-way analysis of variance (ANOVA) analysis, a significance level of 5% and a statistical power of at least 80% to detect a medium effect size (d = 0.5) and thus to show a significant group difference. Based on this background, the optimal sample size is calculated to be a total of 102 subjects. To consider asymmetric subgroups and to allow for a moderate dropout rate and additional calculations (secondary study objectives), we aim to include a total of at least 150 study participants in each group with 25 healthy volunteers as controls.

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with Chronic hepatitis C Infection

Description

Inclusion Criteria:

  • Age 18-65 years and chronic HCV infection.
  • Group A: Patients with hepatitis C (Non-cirrhotic) [n= 150]
  • Group B: Patients with hepatitis C related compensated-cirrhosis [n= 150]
  • Group C: Healthy volunteers [n= 25]

Exclusion Criteria:

  • Current overt hepatic encephalopathy or during the last 1 month
  • TIPS (transjugular intra- hepatic porto-systemic shunt)
  • elective surgery planned within the next 8 weeks
  • unable to give informed consent
  • HIV infection
  • chronic respiratory insufficiency
  • current infection and receiving antibiotics
  • renal failure (serum creatinine ≥ 1.5 mg/l)
  • hepatocellular carcinoma,
  • patient with other neurological disease
  • intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Group A
Chronic hepatitis C without Cirrhosis
Other: Depression and Cognitive Tests
Health Related Quality of Life, neurocognitive tests, PHES
Other Names:
  • SF36
Chronic hepatitis C with Cirrhosis
Other: Depression and Cognitive Tests
Health Related Quality of Life, neurocognitive tests, PHES
Other Names:
  • SF36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive performance
Time Frame: Day 0
Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test)
Day 0
Cognitive performance
Time Frame: 90 days after treatment completion
Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test)
90 days after treatment completion
Cognitive performance using conventional tests
Time Frame: Day 0
Psychometric hepatic encephalopathy score (PHES), Indian Version.
Day 0
Cognitive performance using conventional tests
Time Frame: 90 days after treatment completion
Psychometric hepatic encephalopathy score (PHES), Indian Version.
90 days after treatment completion
HRQOL by SF-36
Time Frame: Day 0
Day 0
HRQOL by SF-36
Time Frame: 90 days after treatment completion
90 days after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Scale
Time Frame: Day 0
Beck's Depression Inventory (BDI) Generalized anxiety disorder (GAD 7 score) Psychometric hepatic encephalopathy Score (PHES) Montreal Cognitive assessment Score (MoCA Score)
Day 0
Depression Scale
Time Frame: 90 days after treatment completion
Beck's Depression Inventory (BDI) Generalized anxiety disorder (GAD 7 score) Psychometric hepatic encephalopathy Score (PHES) Montreal Cognitive assessment Score (MoCA Score)
90 days after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Madhumita Premkumar, DM, Postgraduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC-D3/2018-866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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