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Neurocognitive Performance and Emotional State in HCV Patients With IFN-free Antiviral Therapy

NCT02469012 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-06-11

No results posted yet for this study

Summary

The present study evaluates neurocognitive performance as well as measures of mood, quality of life, and fatigue in patients with chronic hepatitis C infection. In a prospective longitudinal study design, included patients are monitored before, during, and in the long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/- Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post therapy results of sustained virologic responders to corresponding pretreatment values as well as to historic interferon-treatment patients without virological response. It is expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at least in part - reversible by the successful application of modern IFN-free antiviral medication.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Combination #1

Sofosbuvir + Ribavirin

DRUG

Combination #2

Sofosbuvir + Daclatasvir

DRUG

Combination #3

Sofosbuvir + Daclatasvir + Ribavirin

DRUG

Combination #4

Sofosbuvir + Ledipasvir

DRUG

Combination #5

Sofosbuvir + Ledipasvir + Ribavirin

Sponsors & Collaborators

  • University of Wuerzburg

    lead OTHER

Principal Investigators

  • Michael R Kraus, MD, PhD · Kreiskliniken Altötting-Burghausen, Burghausen, Germany

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2017-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469012 on ClinicalTrials.gov