Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Relate… (NCT04330508) | Clinical Trial Compass
CompletedNot Applicable
Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial
India385 participantsStarted 2018-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive performance
Timeframe: Day 0
2
Cognitive performance
Timeframe: 90 days after treatment completion
3
Cognitive performance using conventional tests
Timeframe: Day 0
4
Cognitive performance using conventional tests
Timeframe: 90 days after treatment completion
5
HRQOL by SF-36
Timeframe: Day 0
6
HRQOL by SF-36
Timeframe: 90 days after treatment completion
Trial details
NCT IDNCT04330508
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh