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Cognitive Impairments in Chronic Hepatitis C Patients and Potential Reversibility With New Agents (CICHepC) (CICHepC)

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ClinicalTrials.gov Identifier: NCT02745132
Recruitment Status : Unknown
Verified April 2016 by Instituto de Investigación Marqués de Valdecilla.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

Brief Summary:
The overall aim of this study is to evaluate the prevalence of cognitive impairments and brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes in cognition and brain structure and function after treatment with Direct-acting Antivirals (DAAs).

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Neuropsychological evaluation and Brain MRI Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Personalized Medicine in HCV Infection: Cognitive Impairments and Brain Anomalies in Chronic Hepatitis C Infected Individuals. Characterization and Potential Reversibility With Direct Antiviral Agents.
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cognitive evaluation in HCV patients

Neuropsychological evaluation and Brain MRI

Intervention: The only intervention to be carried out along the study will consist of complete neuro-psychological tests and MRI studies performed at different times.

Chronic HCV patients who are going to be treated with new DAAs according to current guidelines will be studied: A neuro-psychological battery of tests and brain MRI studies will be performed at different times before and after the end of the treatment. The participation in the study will not influence neither the indication to treat nor the treatment used.

Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines

Other: Neuropsychological evaluation and Brain MRI

This is a prospective study. The only intervention planned will consist of performing neuropsychological tests and cerebral MRI that will be carried out on a single group cohort at different times.

Notwithstanding, we will record the exposure to DAA to assess any change in neurocognitive function and MRI imaging.

Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines (1)

(1)European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336.





Primary Outcome Measures :
  1. Changes in Continuous Performance Test (CPT) score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Cognitive impairment, particularly Attention and reaction time


Secondary Outcome Measures :
  1. Changes in Digits forward and backward WAIS-III subtest scores [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Cognitive impairment, particularly Working memory

  2. Changes in Digit symbol WAIS-III subtest score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Information processing speed

  3. Changes in Trail Making Test (TMT) Parts A & B scores [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Information processing speed

  4. Changes in Letter FAS score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Verbal fluency

  5. Changes in animal category subtest score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Verbal fluency

  6. Changes in Rey Auditory Verbal Learning Test (RAVLT) scores [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Learning and memory

  7. Changes in Rey Copy Figure(RCF) scores [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Learning and memory

  8. Changes in Grooved Pegboard score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Motor functioning

  9. Changes in Tower of London score [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Executive functions

  10. Changes in Stroop color-word test scores [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Neuropsychological test to assess Executive functions

  11. Changes in cortical thickness [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Basal Neuroimaging findings in HCV infected patients and changes after DAA treatment (Assesed through structural, diffusion and functional MRI).

  12. Changes in cortical surface área assessed by MRI [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Basal Neuroimaging findings in HCV infected patients and changes after DAA treatment (Assesed through structural, diffusion and functional MRI).

  13. Changes in cortical surface volumen assessed by MRI [ Time Frame: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Basal Neuroimaging findings in HCV infected patients and changes after DAA treatment (Assesed through structural, diffusion and functional MRI).

  14. Sustained Viral Response [ Time Frame: 3, 6 and 12 months after the end of treatment (Sustained Viral Response) ]
    Data on efficacy of treatments

  15. Advers events [ Time Frame: up to 24 weeks ]
    Data on safety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CHC patients 18-75 years old
  • Liver fibrosis ≤ F3 in Fibroscan/liver biopsy
  • Naive or previous failure to a treatment
  • Accept the study and sign the CI

Exclusion Criteria:

  • Does not meet the above criteria
  • VIH or other viral coinfection
  • Hepatocarcinoma
  • Other systemic inflammatory diseases (i.e. RA, etc)
  • Neurodegenerative diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745132


Contacts
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Contact: Javier Crespo García, MDPhD 34 942 202544 javiercrespo1991@gmail.com
Contact: Benedicto Crespo Facorro, MDPhD 34 942 202520 bcfacorro@humv.es

Locations
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Spain
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact: Javier Crespo García, MDPhD    34 942202544    javiercrespo1991@gmail.com   
Contact: Benedicto Crespo Facorro, MDPhD    34 942202520    bcfacorro@humv.es   
Sub-Investigator: Antonio Cuadrado Lavín, MDPhD         
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Ministerio de Economía y Competitividad, Spain
Investigators
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Principal Investigator: Javier Crespo García, MDPhD Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
Principal Investigator: Benedicto Crespo Facorro, MDPhD Head of section Of Psychiatry at University Hospital Marqués de Valdecilla. Proffesor of Psychiatry at Department of Psychiatry, School of Medicine

Publications:
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Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT02745132     History of Changes
Other Study ID Numbers: CICHepC-PIE15/00079-JCG
PIE15/00079 ( Other Grant/Funding Number: Ministerio de Economía y Competitividad, Spain )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Instituto de Investigación Marqués de Valdecilla:
Chronic, Cognition Disorders
Neurocognition Disorders
Cognitive Impairments
Diffusion Magnetic Resonance Imaging
MRI functional
Verbal fluency
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Cognitive Dysfunction
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Cognition Disorders
Neurocognitive Disorders
Mental Disorders