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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Depression in Chronic Hepatitis C

Treatments: Other: Depression and Cognitive Tests

Study type: Observational

Funder types: Other

Identifiers

NCT04330508

IEC-D3/2018-866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

385 participants in 3 patient groups

Group A

Description:

Chronic hepatitis C without Cirrhosis

Treatment:

Other: Depression and Cognitive Tests

Chronic hepatitis C with Cirrhosis

Treatment:

Other: Depression and Cognitive Tests

Healthy Volunteers