HCV InfectionNCT03508115
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
An observational study of HCV Infection and HCV Coinfection, run by Corporacion Parc Tauli.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCV Infection, HCV Coinfection
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2016to 15 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: HCV patients who are candidates to direct antiviral treatment
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
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.
Read the detailed description
The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.
The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.
A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).
The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.
- Conditions
- HCV Infection, HCV Coinfection
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline, change at 6 months after treatment
Secondary outcomes (5)
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.
Measured: baseline, change at 6 months after treatment
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).
Measured: baseline, change at 6 months after treatment
Fibroscan
Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan.
Measured: Baseline, change at 6 months after treatment
HCV RNA
Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients
Measured: Baseline, change at 3 months after treatment, change at 6 months after treatment.
Immunosuppression state
The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start28 Jul 2016
- Primary completion6 Sep 2017
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercè Jodar-Vicente, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508115
- Sponsor's protocol ID
- CIR2015/042
- Status last verified
- Feb 2019
- First submitted
- 28 Mar 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
- ClinicalTrials.gov ID
- NCT03508115
- Acronym / sponsor ID
- CIR2015/042
- Conditions
- HCV Infection, HCV Coinfection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.
The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.
A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).
The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- HCV patients who are candidates to direct antiviral treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Memory tests
Time frame: baseline, change at 6 months after treatment
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.
Attention tests
Time frame: baseline, change at 6 months after treatment
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.
Executive function tests
Time frame: baseline, change at 6 months after treatment
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.
Speed processing test
Time frame: baseline, change at 6 months after treatment
Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed. The direct scores have been transformed into T-scores (mean=50; SD=10).
5 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, change at 6 months after treatment
36-Item Short Form Health Survey (SF-36 )
Time frame: baseline, change at 6 months after treatment
Fibroscan
Time frame: Baseline, change at 6 months after treatment
HCV RNA
Time frame: Baseline, change at 3 months after treatment, change at 6 months after treatment.
Immunosuppression state
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV Infection and HCV Coinfection, run by Corporacion Parc Tauli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory tests (time frame: baseline, change at 6 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.