Status:
COMPLETED
Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Depression in Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
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 impai...
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 ins...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT04330508
Start Date
March 1 2018
End Date
December 31 2021
Last Update
February 13 2024
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012