NCT04330508|CompletedDMC
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Sponsor study identifier
observational
385
1 country
1
Study Start
March 1, 2018
Actual (reported)Primary Completion
October 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2018
Actual (reported)March 23, 2020
Actual (reported)April 1, 2020
Actual (reported)October 31, 2021
Actual (reported)December 31, 2021
Actual (reported)Cognitive performance
Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test)
Day 0
Cognitive performance
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
Psychometric hepatic encephalopathy score (PHES), Indian Version.
Day 0
Cognitive performance using conventional tests
Psychometric hepatic encephalopathy score (PHES), Indian Version.
90 days after treatment completion
HRQOL by SF-36
Day 0
Depression Scale
Day 0
Depression Scale
90 days after treatment completion
Chronic hepatitis C without Cirrhosis
Health Related Quality of Life, neurocognitive tests, PHES
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with Chronic hepatitis C Infection
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012, India
Butterworth RF. Editorial: rifaximin and minimal hepatic encephalopathy. Am J Gastroenterol. 2011 Feb;106(2):317-8. doi: 10.1038/ajg.2010.460.
Poordad FF. Review article: the burden of hepatic encephalopathy. Aliment Pharmacol Ther. 2007 Feb;25 Suppl 1:3-9. doi: 10.1111/j.1746-6342.2006.03215.x.
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.
Madhumita Premkumar, DM
Post Graduate Institute of Medical Education and Research, Chandigarh
385 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2020
First Posted
April 1, 2020
Study Start
March 1, 2018
Actual (reported)HRQOL by SF-36
90 days after treatment completion
Contact the study team to confirm eligibility.
Kircheis G, Knoche A, Hilger N, Manhart F, Schnitzler A, Schulze H, Haussinger D. Hepatic encephalopathy and fitness to drive. Gastroenterology. 2009 Nov;137(5):1706-15.e1-9. doi: 10.1053/j.gastro.2009.08.003. Epub 2009 Aug 15.
Ortiz M, Cordoba J, Jacas C, Flavia M, Esteban R, Guardia J. Neuropsychological abnormalities in cirrhosis include learning impairment. J Hepatol. 2006 Jan;44(1):104-10. doi: 10.1016/j.jhep.2005.06.013. Epub 2005 Jul 11.
Bajaj JS, Schubert CM, Heuman DM, Wade JB, Gibson DP, Topaz A, Saeian K, Hafeezullah M, Bell DE, Sterling RK, Stravitz RT, Luketic V, White MB, Sanyal AJ. Persistence of cognitive impairment after resolution of overt hepatic encephalopathy. Gastroenterology. 2010 Jun;138(7):2332-40. doi: 10.1053/j.gastro.2010.02.015. Epub 2010 Feb 20.
Bajaj JS, Saeian K, Schubert CM, Hafeezullah M, Franco J, Varma RR, Gibson DP, Hoffmann RG, Stravitz RT, Heuman DM, Sterling RK, Shiffman M, Topaz A, Boyett S, Bell D, Sanyal AJ. Minimal hepatic encephalopathy is associated with motor vehicle crashes: the reality beyond the driving test. Hepatology. 2009 Oct;50(4):1175-83. doi: 10.1002/hep.23128.
Conn HO. Trailmaking and number-connection tests in the assessment of mental state in portal systemic encephalopathy. Am J Dig Dis. 1977 Jun;22(6):541-50. doi: 10.1007/BF01072510. No abstract available.
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.
Primary Completion
October 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
February 13, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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