Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03674125 - Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection Phase 1
Completed NCT00978497 - Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection Phase 2
Completed NCT00170131 - MMF Influence on HCV Viral Evolution After Liver Transplantation Phase 4
Completed NCT04008927 - A Community-based Intervention Among Active Drug Users in Montpellier N/A
Active, not recruiting NCT04044586 - HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
Completed NCT01958281 - Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency Phase 2
Completed NCT02533427 - Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol Phase 1
Completed NCT02783976 - Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice
Withdrawn NCT04309734 - Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects Phase 1/Phase 2
Completed NCT01965535 - Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection Phase 2
Completed NCT00768690 - A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 Phase 1
Completed NCT00743795 - Safety, Tolerability, and Antiviral Activity of 24 or 48 Weeks of GS-9190 in Combination With Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection Phase 2
Withdrawn NCT04235049 - Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE) Phase 4
Terminated NCT00401947 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection Phase 2
Completed NCT00959699 - A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4) Phase 2
Completed NCT00623649 - Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection Phase 1
Completed NCT00221624 - Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients Phase 3
Completed NCT04134767 - Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) N/A
Completed NCT02402452 - Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment Phase 1
Terminated NCT00874796 - Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection Phase 2