NCT00227149

Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C

Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C Infection and a Former (Peg)Interferon Alfa-2b-Based Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: University of Wuerzburg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy. M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen Questions: * Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment? * At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication? * At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life? * In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance? * Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?

Detailed description

This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy. M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen Questions: * Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment? * At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication? * At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life? * Can the results of the current and previous studies be confirmed by alternative / additional psychometric instruments in specified subsample? (Fatigue Impact Scale; FIS-D, SF-36) * In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance? * Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, is emotional state and - above all - neurocognitive performance significantly improved even in the absence of severe liver damage? Methods: * Multifactorial analysis of test results: pre- vs. post-therapy; sustained virological response vs. nonresponse/relapse. * Psychometric evaluation instruments / psychometric questionnaires (HADS-D, SCL-90-R, Subsample : SF-36, FIS-D) * Evaluation of neurocognitive performance by the Test battery of Attentional Performance (TAP) * Evaluation in a prospective, longitudinal study design. Planned sample size / sample size considerations * N = 150 patients (hepatitis C patients in a longitudinal study design: t1\[before onset of interferon therapy\] … t5\[at least 12 months after the end of antiviral treatment\] Power calculations / power considerations: * Given: 2-factorial design (time course x SVR); type I error = 0.050; type II error = 0.20 (power = 0.80) - as usually assumed in clinical trials. * With respect to the independent factor SVR ("sustained virological response", 2 factor levels), optimum / optimal sample sizes range from 42 (large effect size d = 0.8) to 102 (medium effect size d = 0.5). Smaller effect sizes - according to previous work in this field - do not appear to bear any clinical relevance. * (Pairwise comparisons of dependent samples \[e.g. pre- vs. post-therapy or pre-therapy vs. long-term follow-up\] require even smaller optimal sample sizes ranging from 16 to 43 for large or medium effect sizes.) Patient recruitment: * Patients with chronic hepatitis C infection and therapy with (peg)interferon alfa-2b. * Patients with informed written consent (with respect) to a long-term follow-up of psychiatric side effects and neurocognitive performance. * Patients with baseline monitoring of neuropsychiatric symptoms and neurocognitive performance.

Conditions

• Hepatitis C, Chronic

Timeline

• Start date: 2005-07-01
• Completion: 2008-08-01
• First posted: 2005-09-27
• Last updated: 2009-02-04

Locations

1 site across 1 country: Germany