Neurocognitive Performance and Emotional State in HCV Patients With IFN-free Antiviral Therapy (IFNfreeCOG)
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|ClinicalTrials.gov Identifier: NCT02469012|
Recruitment Status : Unknown
Verified June 2015 by Arne Schaefer, University of Wuerzburg.
Recruitment status was: Recruiting
First Posted : June 11, 2015
Last Update Posted : June 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Combination #1 Drug: Combination #2 Drug: Combination #3 Drug: Combination #4 Drug: Combination #5||Not Applicable|
Chronic hepatitis C is one of the most frequent infectious diseases worldwide and a major cause of chronic liver disease. At diagnosis, approximately 20 % of patients with chronic hepatitis C already have liver cirrhosis.
Therapy for hepatitis C has meanwhile reached a high level of efficacy and effectiveness: at present, about 90 % of patients treated with a combination of peginterferon alfa, ribavirin and sofosbuvir for up to 12 weeks will reach a sustained loss of hepatitis C virus.
Psychiatric side effects of interferon alfa are well known and may require dose reduction or even premature discontinuation of therapy.
As patients on interferon treatment sometimes report concentration or memory impairment that in some cases interferes considerably with their capacity to manage the requirements of everyday life, the investigators planned and intend to conduct a prospective and longitudinal study evaluating - among other parameters - neurocognitive performance before, during, and after therapy with an antiviral IFN-free therapy.
In previously performed scientific work, the investigators were able to show that interferon-based combination therapy of chronic hepatitis C may cause reversible impairment of neurocognitive performance during treatment period. Moreover, the investigators have recently demonstrated that successful IFN-based antiviral treatment (criterion: SVR, sustained virological response) leads to significant improvement of relevant aspects of attentional and neurocognitive performance. These results indicate that HCV-related neurocognitive impairment is potentially reversible.
Nevertheless, there are still open questions and important issues to be addressed in connection with this field of research, especially regarding several aspects IFN-free antiviral therapy:
Questions to be answered:
- At least 12 months after the end of successfully performed IFN-free antiviral treatment - are psychometrically assessed parameters related to patients' quality of life, fatigue, neurocognitive performance, and mood significantly improved as compared to pretreatment (i.e., baseline) values?
- At least12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response (special to historical group of IFN-treated patients without a sustained virological response) with respect to neurocognitive performance, emotional state, fatigue and quality of life?
- In the absence of a clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance? Is it possible to confirm the respective findings yielded in the context of former interferon-based treatment regimens?
- With the current and upcoming IFN-free treatment options - are there still any significant therapy-related changes in symptom areas such as neurocognitive performance, mood or fatigue?
Prospective monocentric study with a longitudinal repeated measures design including hepatitis C patients with indication for standard IFN-free antiviral therapy (sofosbuvir/daclatasvir +/- ribavirin; sofosbuvir/ledipasvir +/- ribavirin) and a long-term follow-up of quality of life, neurocognitive performance, fatigue, and emotional state. Planned sample size: n = 30 hepatitis C patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Quality of Life, Neurocognitive Performance, Fatigue, and Emotional State in HCV Patients Before, During, and in the (Long-term) Follow-up of an IFN-free Antiviral Therapy|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
Drug: Combination #1
Sofosbuvir + Ribavirin
Other Name: Sofosbuvir + Ribavirin
Drug: Combination #2
Sofosbuvir + Daclatasvir
Other Name: Sofosbuvir + Daclatasvir
Drug: Combination #3
Sofosbuvir + Daclatasvir + Ribavirin
Other Name: Sofosbuvir + Daclatasvir + Ribavirin
Drug: Combination #4
Sofosbuvir + Ledipasvir
Other Name: Sofosbuvir + Ledipasvir
Drug: Combination #5
Sofosbuvir + Ledipasvir + Ribavirin
Other Name: Sofosbuvir + Ledipasvir + Ribavirin
- Change in Neurocognitive Performance (computerized TAP - Test Battery for Attentional Performance) [ Time Frame: evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy ]assessment of changes over treatment time (repeated measures design)
- Change in Fatigue (Fatigue Impact Scale - FIS-D, questionnaire) [ Time Frame: evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy ]assessment of changes over treatment time (repeated measures design)
- Change in Health-Related Quality of Life (SF-36, questionnaire) [ Time Frame: evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy ]assessment of changes over treatment time (repeated measures design)
- Change in Emotional State (Hospital Anxiety and Depression Scale HADS, questionnaire) [ Time Frame: evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy ]assessment of changes over treatment time (repeated measures design)
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): NCT02469012
|Contact: Arne Schäfer, PhD||+49931201402 ext firstname.lastname@example.org|
|Contact: Michael R Kraus, MD, PhD||+4986778801 ext email@example.com|
|Kreiskliniken Altötting-Burghausen, Medizinische Klinik II||Recruiting|
|Burghausen, Bavaria, Germany, 84489|
|Contact: Michael R Kraus, MD, PhD +4986778801 ext 41 firstname.lastname@example.org|
|Principal Investigator:||Michael R Kraus, MD, PhD||Kreiskliniken Altötting-Burghausen, Burghausen, Germany|