NCT02745132

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

April 10, 2016

Last Update Submit

April 19, 2016

Conditions

Hepatitis C

Keywords

Chronic, Cognition DisordersNeurocognition DisordersCognitive ImpairmentsDiffusion Magnetic Resonance ImagingMRI functionalVerbal fluency

Outcome Measures

Primary Outcomes (1)

  • Changes in Continuous Performance Test (CPT) score

    Neuropsychological test to assess Cognitive impairment, particularly Attention and reaction time

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

Secondary Outcomes (15)

  • Changes in Digits forward and backward WAIS-III subtest scores

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

  • Changes in Digit symbol WAIS-III subtest score

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

  • Changes in Trail Making Test (TMT) Parts A & B scores

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

  • Changes in Letter FAS score

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

  • Changes in animal category subtest score

    Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)

  • +10 more secondary outcomes

Study Arms (1)

Cognitive evaluation in HCV patients

OTHER

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

Interventions

Neuropsychological evaluation and Brain MRIOTHER

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.

Cognitive evaluation in HCV patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (4)

  • Byrnes V, Miller A, Lowry D, Hill E, Weinstein C, Alsop D, Lenkinski R, Afdhal NH. Effects of anti-viral therapy and HCV clearance on cerebral metabolism and cognition. J Hepatol. 2012 Mar;56(3):549-56. doi: 10.1016/j.jhep.2011.09.015. Epub 2011 Oct 23.

    PMID: 22027578BACKGROUND

  • Fletcher NF, Wilson GK, Murray J, Hu K, Lewis A, Reynolds GM, Stamataki Z, Meredith LW, Rowe IA, Luo G, Lopez-Ramirez MA, Baumert TF, Weksler B, Couraud PO, Kim KS, Romero IA, Jopling C, Morgello S, Balfe P, McKeating JA. Hepatitis C virus infects the endothelial cells of the blood-brain barrier. Gastroenterology. 2012 Mar;142(3):634-643.e6. doi: 10.1053/j.gastro.2011.11.028. Epub 2011 Dec 1.

    PMID: 22138189BACKGROUND

  • Kraus MR, Schafer A, Teuber G, Porst H, Sprinzl K, Wollschlager S, Keicher C, Scheurlen M. Improvement of neurocognitive function in responders to an antiviral therapy for chronic hepatitis C. Hepatology. 2013 Aug;58(2):497-504. doi: 10.1002/hep.26229. Epub 2013 Jun 24.

    PMID: 23300053BACKGROUND

  • Bajaj JS, Forton DM. Cognitive improvement after HCV eradication: Extending the benefits. Hepatology. 2013 Aug;58(2):480-2. doi: 10.1002/hep.26481. Epub 2013 Jun 25. No abstract available.

    PMID: 23696270BACKGROUND

MeSH Terms

Conditions

Hepatitis CBronchiolitis Obliterans SyndromeCognition DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Crespo García, MDPhD

CONTACT

34 942 202544javiercrespo1991@gmail.com

Benedicto Crespo Facorro, MDPhD

CONTACT

34 942 202520bcfacorro@humv.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2016

First Posted

April 20, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)