Hepatitis C, ChronicNCT00227149
Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C
An observational study of Hepatitis C, Chronic, run by University of Wuerzburg at 1 site in Germany.
Trial summary
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy. M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 197 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCV outpatients (University Hospital)
Who may be able to join
- Patients with chronic hepatitis C and indication for interferon-based antiviral therapy.
- Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
- Age of study participants: between 18 and 65 years.
- All patients need to have documented antibodies to hepatitis C virus (HCV) and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV Monitor™ test, Roche Diagnostics)
Who cannot join
- Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, test battery of attentional performance).
- Further Exclusion Criteria:
- Age under 18 years or over 65 years
- Coinfections such as hepatitis B virus or human immunodeficiency virus
- Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
- Major depressive disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria), psychosis, active intravenous drug use or alcohol abuse.
- These additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis C infection.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Med. Klinik und Poliklinik II, University of Wuerzburg
Würzburg, 97070
About this study
Official title: Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C Infection and a Former (Peg)Interferon Alfa-2b-Based Therapy
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Read more
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- In the absence of 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?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?
Read the detailed description
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- Can the results of the current and previous studies be confirmed by alternative / additional psychometric instruments in specified subsample? (Fatigue Impact Scale; FIS-D, SF-36)
- In the absence of 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?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, is emotional state and - above all - neurocognitive performance significantly improved even in the absence of severe liver damage?
Methods:
- Multifactorial analysis of test results: pre- vs. post-therapy; sustained virological response vs. nonresponse/relapse.
- Psychometric evaluation instruments / psychometric questionnaires (HADS-D, SCL-90-R, Subsample : SF-36, FIS-D)
- Evaluation of neurocognitive performance by the Test battery of Attentional Performance (TAP)
- Evaluation in a prospective, longitudinal study design.
Planned sample size / sample size considerations
- N = 150 patients (hepatitis C patients in a longitudinal study design: t1[before onset of interferon therapy] … t5[at least 12 months after the end of antiviral treatment]
Power calculations / power considerations:
- Given: 2-factorial design (time course x SVR); type I error = 0.050; type II error = 0.20 (power = 0.80) - as usually assumed in clinical trials.
- With respect to the independent factor SVR ("sustained virological response", 2 factor levels), optimum / optimal sample sizes range from 42 (large effect size d = 0.8) to 102 (medium effect size d = 0.5). Smaller effect sizes - according to previous work in this field - do not appear to bear any clinical relevance.
- (Pairwise comparisons of dependent samples [e.g. pre- vs. post-therapy or pre-therapy vs. long-term follow-up] require even smaller optimal sample sizes ranging from 16 to 43 for large or medium effect sizes.)
Patient recruitment:
- Patients with chronic hepatitis C infection and therapy with (peg)interferon alfa-2b.
- Patients with informed written consent (with respect) to a long-term follow-up of psychiatric side effects and neurocognitive performance.
- Patients with baseline monitoring of neuropsychiatric symptoms and neurocognitive performance.
- Conditions
- Hepatitis C, Chronic
- Keywords
- C06.552.380.705.440
- Medical subject headings
- Hepatitis C, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startJul 2005
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Michael R. Kraus, MD, PhD, Principal investigator, Med. Klinik und Poliklinik II, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227149
- Sponsor's protocol ID
- PO 4406
- Status last verified
- Feb 2009
- First submitted
- 23 Sep 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. doi: 10.1016/j.clpt.2004.09.007.
PubMed 15637534Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614.
PubMed 12823087Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Paroxetine for the treatment of interferon-alpha-induced depression in chronic hepatitis C. Aliment Pharmacol Ther. 2002 Jun;16(6):1091-9. doi: 10.1046/j.1365-2036.2002.01265.x.
PubMed 12030950Kraus MR, Schafer A, Scheurlen M. Paroxetine for the prevention of depression induced by interferon alfa. N Engl J Med. 2001 Aug 2;345(5):375-6. No abstract available.
PubMed 11484704
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C Infection and a Former (Peg)Interferon Alfa-2b-Based Therapy
- ClinicalTrials.gov ID
- NCT00227149
- Acronym / sponsor ID
- PO 4406
- Conditions
- Hepatitis C, Chronic
- Keywords
- C06.552.380.705.440
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jul 2005
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- In the absence of 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?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?
Detailed description
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- Can the results of the current and previous studies be confirmed by alternative / additional psychometric instruments in specified subsample? (Fatigue Impact Scale; FIS-D, SF-36)
- In the absence of 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?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, is emotional state and - above all - neurocognitive performance significantly improved even in the absence of severe liver damage?
Methods:
- Multifactorial analysis of test results: pre- vs. post-therapy; sustained virological response vs. nonresponse/relapse.
- Psychometric evaluation instruments / psychometric questionnaires (HADS-D, SCL-90-R, Subsample : SF-36, FIS-D)
- Evaluation of neurocognitive performance by the Test battery of Attentional Performance (TAP)
- Evaluation in a prospective, longitudinal study design.
Planned sample size / sample size considerations
- N = 150 patients (hepatitis C patients in a longitudinal study design: t1[before onset of interferon therapy] … t5[at least 12 months after the end of antiviral treatment]
Power calculations / power considerations:
- Given: 2-factorial design (time course x SVR); type I error = 0.050; type II error = 0.20 (power = 0.80) - as usually assumed in clinical trials.
- With respect to the independent factor SVR ("sustained virological response", 2 factor levels), optimum / optimal sample sizes range from 42 (large effect size d = 0.8) to 102 (medium effect size d = 0.5). Smaller effect sizes - according to previous work in this field - do not appear to bear any clinical relevance.
- (Pairwise comparisons of dependent samples [e.g. pre- vs. post-therapy or pre-therapy vs. long-term follow-up] require even smaller optimal sample sizes ranging from 16 to 43 for large or medium effect sizes.)
Patient recruitment:
- Patients with chronic hepatitis C infection and therapy with (peg)interferon alfa-2b.
- Patients with informed written consent (with respect) to a long-term follow-up of psychiatric side effects and neurocognitive performance.
- Patients with baseline monitoring of neuropsychiatric symptoms and neurocognitive performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV outpatients (University Hospital)
Key inclusion criteria (4 listed)
- Patients with chronic hepatitis C and indication for interferon-based antiviral therapy.
- Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
- Age of study participants: between 18 and 65 years.
- All patients need to have documented antibodies to hepatitis C virus (HCV) and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV Monitor™ test, Roche Diagnostics)
Key exclusion criteria (7 listed)
- Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, test battery of attentional performance).
- Age under 18 years or over 65 years
- Coinfections such as hepatitis B virus or human immunodeficiency virus
- Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
- Major depressive disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria), psychosis, active intravenous drug use or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Background: PubMed 15637534Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. doi: 10.1016/j.clpt.2004.09.007.
- Background: PubMed 12823087Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614.
- Background: PubMed 12030950Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Paroxetine for the treatment of interferon-alpha-induced depression in chronic hepatitis C. Aliment Pharmacol Ther. 2002 Jun;16(6):1091-9. doi: 10.1046/j.1365-2036.2002.01265.x.
- Background: PubMed 11484704Kraus MR, Schafer A, Scheurlen M. Paroxetine for the prevention of depression induced by interferon alfa. N Engl J Med. 2001 Aug 2;345(5):375-6. No abstract available.
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R. Kraus, MD, PhD principal investigator
Med. Klinik und Poliklinik II, University of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227149, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.