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

NCT ID: NCT04330508

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-12-31

Brief 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.

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.

Conditions

Depression in Chronic Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Chronic hepatitis C without Cirrhosis

Depression and Cognitive Tests

Intervention Type: OTHER

Health Related Quality of Life, neurocognitive tests, PHES

Chronic hepatitis C with Cirrhosis

Depression and Cognitive Tests

Intervention Type: OTHER

Health Related Quality of Life, neurocognitive tests, PHES

Healthy Volunteers

No interventions assigned to this group

Interventions

Depression and Cognitive Tests

Health Related Quality of Life, neurocognitive tests, PHES

Intervention Type: OTHER

Other Intervention Names

SF36

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Madhumita Premkumar

Assistant professor, Department of heaptology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhumita Premkumar, DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Countries

India

References

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Reference Type: BACKGROUND

PMID: 21301455 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17295846 (View on PubMed)

Amodio P, Montagnese S, Gatta A, Morgan MY. Characteristics of minimal hepatic encephalopathy. Metab Brain Dis. 2004 Dec;19(3-4):253-67. doi: 10.1023/b:mebr.0000043975.01841.de.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Kaur H, Dhiman RK, Kulkarni AV, Premkumar M, Singh V, Duseja AK, Grover S, Grover GS, Roy A, Verma N, De A, Taneja S, Mehtani R, Mishra S, Kaur H. Improvement of chronic HCV infection-related depression, anxiety, and neurocognitive performance in persons achieving SVR-12: A real-world cohort study. J Viral Hepat. 2022 May;29(5):395-406. doi: 10.1111/jvh.13668. Epub 2022 Mar 17.

Reference Type: DERIVED

PMID: 35266624 (View on PubMed)

Other Identifiers

IEC-D3/2018-866

Identifier Type: -

Identifier Source: org_study_id