Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C - Full Text View

Sponsors and Collaborators:	University of Wuerzburg Schering-Plough
Information provided by:	University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT00227149

Purpose

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?

Condition
Hepatitis C, Chronic

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by University of Wuerzburg:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

HCV outpatients (University Hospital)

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227149

Locations

Germany
Med. Klinik und Poliklinik II, University of Wuerzburg
Wuerzburg, Germany, 97070

Sponsors and Collaborators

University of Wuerzburg

Schering-Plough

Investigators

Principal Investigator:

Michael R. Kraus, MD, PhD

Med. Klinik und Poliklinik II, University of Wuerzburg

More Information

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.

Kraus 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.

Kraus 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.

Kraus 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.

Responsible Party:	University of Wuerzburg ( Michael R Kraus, MD, PhD )
Study ID Numbers:	PO 4406
Study First Received:	September 23, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00227149
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Wuerzburg:

C06.552.380.705.440

Study placed in the following topic categories:

Interferon-alpha
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Hepatitis, Viral, Human
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009