Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
NCT03508115, Completed, Corporacion Parc Tauli
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents | ClinicalTrials.gov |
| NCT number | NCT03508115 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 80 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Corporacion Parc Tauli | ClinicalTrials.gov |
| Conditions | HCV Infection, HCV Coinfection | ClinicalTrials.gov |
| First posted | 2018-04-25 | ClinicalTrials.gov |
| Last updated | 2019-02-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Memory tests | 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. | ClinicalTrials.gov |
| Primary | Attention tests | 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. | ClinicalTrials.gov |
| Primary | Executive function tests | 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. | ClinicalTrials.gov |
| Primary | Speed processing test | 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). | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | baseline, change at 6 months after treatment | 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. | ClinicalTrials.gov |
| Secondary | 36-Item Short Form Health Survey (SF-36 ) | baseline, change at 6 months after treatment | 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). | ClinicalTrials.gov |
| Secondary | Fibroscan | Baseline, change at 6 months after treatment | Degree of fibrosis: Speed of propagation of elastic waves measured with fibroscan. | ClinicalTrials.gov |
| Secondary | HCV RNA | Baseline, change at 3 months after treatment, change at 6 months after treatment. | Viral load quantity measured by plasma HCV RNA is collected in HIV co-infected patients | ClinicalTrials.gov |
| Secondary | Immunosuppression state | Baseline | The next cells were analyzed in blood, in HIV co-infected patients : CD4, %CD4, nadir CD4, CD8, % CD8, CD4/CD8 ratio. | ClinicalTrials.gov |
| Other | Blood Biomarkers measures | 1 day pretreatment and change at 6 months post treatment | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Tower Planning | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)