HCV Infection Clinical Trial
Official title:
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
NCT number | NCT03508115 |
Other study ID # | CIR2015/042 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 28, 2016 |
Est. completion date | December 15, 2018 |
Verified date | February 2019 |
Source | Corporacion Parc Tauli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 15, 2018 |
Est. primary completion date | September 6, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood Biomarkers measures | The next blood biomarkers were collected: Brain-derived neurotrophic factor (BDNF); Interleukine 6 (Il-6); Tumor Necrosis Factor (TNF-a ); Glial fibrillary acidic protein (GFAP); Soluble SCD 14 (sCD14) ; Neuro-specific enolase (NSE). | 1 day pretreatment and change at 6 months post treatment | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Hospital Anxiety and Depression Scale (HADS) | It is a self-registering scale of 14 items: 7 items evaluating anxiety and 7 items evaluating depression (Zigmond & Snaith, 1983). Scoring range: 0-21 for each subscale. Scores >10 in each subscale imply a significant anxious/depressive symptomatology. |
baseline, change at 6 months after treatment | |
Secondary | 36-Item Short Form Health Survey (SF-36 ) | It is a self-registered scale for the assessment of quality of life ( Alonso y cols. , 1995). It consists on 8 dimensions: Physical functioning, limitations for physical issues, corporal pain, social functioning, mental health, limitations for emotional issues, vitality and general perception of the own health. For each dimension, the scoring range goes from 0 to 100, where higher values represent better outcome (better quality of life/less limitations/better functioning). | baseline, change at 6 months after treatment | |
Secondary | Fibroscan | Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan. | Baseline, change at 6 months after treatment | |
Secondary | HCV RNA | Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients | Baseline, change at 3 months after treatment, change at 6 months after treatment. | |
Secondary | Immunosuppression state | The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio. | Baseline |
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