Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents

NCT03508115 | Completed

• 1 other identifier: CIR2015/042
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study about the improvement of cognitive, psychopathological and functional abilities in Hepatitis C Virus (HCV) infected patients after eradication of the virus with direct antiviral agents.

Conditions

HCV Infection; HCV Coinfection

Outcome Measures

Primary Outcomes (4)

• Memory tests

  Rey Auditory Verbal Learning Test (RVLT, Spreen \& Strauss 1998) assesses verbal learning, recall and recognition memory; Wechsler Adults Intelligence Scale III backward digits subtest (WAIS, Wechsler 1997) assesses working memory. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single memory component.

  baseline, change at 6 months after treatment

• Attention tests

  Continous Performance Test (CPT, Conners 2000) assesses sustained attention, inattentiveness and impulsivity; WAIS forward digits subtest (WAIS III, Wechsler 1997) assesses attention. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single attention component.

  baseline, change at 6 months after treatment

• Executive function tests

  Stroop Test (Stroop, 1935) assesses flexibility and inhibition of automatic responses; Trail Making Test (TMTA-B Reitan, 1993) assesses visual tracking and flexibility, phonetic and semantic fluency tests (Lezak, 1995) assess verbal fluency; Tower of London (Culbertson \& Zillmer, 2005) assesses visual reasoning and planification. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single executive function component.

  baseline, change at 6 months after treatment

• Speed processing test

  Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed. The direct scores have been transformed into T-scores (mean=50; SD=10).

  baseline, change at 6 months after treatment

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  baseline, change at 6 months after treatment

• 36-Item Short Form Health Survey (SF-36 )

  baseline, change at 6 months after treatment

• Fibroscan

  Baseline, change at 6 months after treatment

• HCV RNA

  Baseline, change at 3 months after treatment, change at 6 months after treatment.

• Immunosuppression state

  Baseline

Other Outcomes (1)

• Blood Biomarkers measures

  1 day pretreatment and change at 6 months post treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCV patients who are candidates to direct antiviral treatment

You may qualify if:

• Patients over 18 years old with indication to receive antiviral treatment
• Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection

You may not qualify if:

• Active alcohol consumption\> 40g daily or history of chronic alcoholism
• Active consumption of other toxics (heroin, cocaine, cannabis)
• Patients with minimum hepatic encephalopathy
• Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions.
• Active use of psychotropics or benzodiazepines

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 25, 2018
• Study Start: July 28, 2016
• Primary Completion: September 6, 2017
• Study Completion: December 15, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-02