Study of Cerebral Function in Patients With Chronic Hepatitis C Infection (HCV/CNS)
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ClinicalTrials.gov Identifier: NCT00788918 |
Recruitment Status
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Completed
First Posted
: November 11, 2008
Last Update Posted
: January 11, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | November 10, 2008 | |||
First Posted Date ICMJE | November 11, 2008 | |||
Last Update Posted Date | January 11, 2013 | |||
Study Start Date ICMJE | November 2008 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Neuropsychological test results, cytokine profile and MRI findings [ Time Frame: 8 weeks before starting IFN+RIB therapy ] Assessment performed before starting antiviral treatment in patients with chronic hepatitis C who awaits treatment. HCV patients without pending treatment will be tested in conjunction with their outpatient controls.
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Original Primary Outcome Measures ICMJE |
Pre- and posttreatment neuropsychological (cognitive) test performance. [ Time Frame: 24/48 weeks Rx plus 24 weeks follow-up ] | |||
Change History | Complete list of historical versions of study NCT00788918 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Interferon-induced depression [ Time Frame: 8-12 weeks after treatment inititation ] | |||
Original Secondary Outcome Measures ICMJE |
Pre and post treatment cerebral MRI and MR spectroscopic examination. [ Time Frame: 24/48 weeks Rx plus 24 weeks follow-up ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Cerebral Function in Patients With Chronic Hepatitis C Infection (HCV/CNS) | |||
Official Title ICMJE | Study of Cerebral Function in Patients With Chronic Hepatitis C Infection Before and After Pegylated Interferon Alfa-2a and Ribavirin Therapy | |||
Brief Summary | 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 1,2,3 and 4) by use of a neuropsychiatric test battery. Furthermore, the patients will 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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE |
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Intervention ICMJE | Drug: Interferon and ribavirin
Interferon 180 microgram weekly s.c. and ribavirin (800/100/1200 mg daily) p.o.
Other Name: Pegasys (ATC Code: L03AB11) and Copegus (ATC Code: J05AB04) |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
100 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date | November 2012 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00788918 | |||
Other Study ID Numbers ICMJE | SKS-0078-HCVCNS EudraCT 2007-005707-18 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Aarhus ( Aarhus University Hospital ) | |||
Study Sponsor ICMJE | Aarhus University Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Aarhus | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |