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Study 13 of 25 for search of: | "Encephalomyelitis" |
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Sponsors and Collaborators: |
University of Aarhus Aarhus University Hospital |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00788918 |
Patients with HCV infection often suffer from chronic fatigue, depression and reduced cognition, even before evolving severe liver fibrosis, liver cirrhosis and hepatic encephalopathy.
It is currently unclear to what extent the symptoms er due to a direct pathological effects of the virus itself, or due to pre-existing psychiatric disease. There is a complex relationship between prior or existing drug abuse, psychiatric disease and HCV infection, that makes it difficult to establish cause-effect relationships.
A biological mechanism has been suggested to contribute to development of cerebral dysfunction in the patients. According to the prevailing Trojan Horses hypothesis circulating lymphocytes cross the blood brain barrier carrying HCV to the central nervous system and virus is subsequently replicated in the macrophages and the microglia in brain as a separate compartment. As part of the immunological response to viral replication, neurodegenerative processes takes place with a harmful effect on the neural circuit and cerebral function. Identification of HCV RNA negative strand, a replication product, in brain tissue from HCV patients, as part of autopsy studies, supports the hypothesis. Moreover, HCV patients have also been observed with abnormal metabolic concentrations in the frontal white substance and the basal ganglia by MRI spectroscopy compared to control groups.
The overall study objective is to assess cerebral function with particular emphasis on cognitive functions in HCV patients (genotypes 1,2 and 3) receiving peginterferon and ribavirin therapy by use of a neuropsychiatric test battery. Furthermore, the patients will in the same pre- and post-treatment study design be examined by MRI, including magnetization transfer, diffusion tensor and contrast perfusion, in order to perform measurements of cerebral volumetric and microstructure. Finally, HCV analysis, including viral sequences and cytokine profiles, in serum and cerebrospinal fluid will be carried out in the study population.
Condition | Intervention |
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Hepatitis C, Chronic Cognition Disorders Fatigue Syndrome, Chronic Major Depressive Disorder |
Drug: Interferon and ribavirin |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Study of Cerebral Function in Patients With Chronic Hepatitis C Infection Before and After Pegylated Interferon Alfa-2a and Ribavirin Therapy |
Estimated Enrollment: | 120 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Interferon and Ribavirin: Experimental
60 Chronic HCV patients with pending antiviral treatment
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Drug: Interferon and ribavirin
Interferon 180 microgram weekly s.c. and ribavirin (800/100/1200 mg daily) p.o.
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HCV control patients: No Intervention
40 HCV patients with mild liver affection without pending antiviral therapy
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Healthy Controls: No Intervention
20 age, sex and education matched controls
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter Leutscher, MD, PhD | +4589498351 | APD@sks.aaa.dk |
Contact: Alex Laursen, MD, DMSc | +4589498351 | ALE@sks.aaa.dk |
Denmark, Jylland | |
Department of Infectious Diseases, Aarhus University Hospital, Skejby | Recruiting |
Aarhus, Jylland, Denmark, 8200 | |
Contact: Peter Leutscher, MD, PhD +4589498351 APD@sks.aaa.dk | |
Contact: Alex Laursen, MD, DMSc +4589498351 ALE@sks.aaa.dk | |
Principal Investigator: Peter Leutscher, MD, PhD |
Principal Investigator: | Peter Leutscher, MD, PhD | Aarhus University Hospital, Dept. Infectious Diseases |
Responsible Party: | Department of Infectious Diseases, Skejby Hospital, Aarhus University Hospital ( Peter Derek Christian Leutscher, MD, PhD ) |
Study ID Numbers: | SKS-0078-HCVCNS, EudraCT 2007-005707-18 |
Study First Received: | November 10, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00788918 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Chronic Hepatitis C cognitive dysfunction MRI MR spectroscopy |
interferon ribavirin sustained virologic response, major depressive disorder |
Liver Diseases Hepatitis, Chronic Ribavirin Hepatitis, Viral, Human Encephalomyelitis Depressive Disorder, Major Fatigue Syndrome, Chronic Musculoskeletal Diseases Neuromuscular Diseases Mental Disorders Hepatitis C Dementia Delirium Interferon-alpha Depression |
Fatigue Interferons Central Nervous System Diseases Depressive Disorder Cognition Disorders Behavioral Symptoms Hepatitis Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Muscular Diseases Digestive System Diseases Mood Disorders Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Flaviviridae Infections Antineoplastic Agents Therapeutic Uses Nervous System Diseases Antiviral Agents Pharmacologic Actions |