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Completed

NCT Number: NCT00788918

Study of Cerebral Function in Patients With Chronic Hepatitis C Infection (HCV/CNS)

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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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Cognition Disorders Cognitive Dysfunction Communicable Diseases Depressive Disorder Depressive Disorder, Major Digestive System Diseases Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Major Depressive Disorder Mental Disorders Mood Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Infectious Diseases, Aarhus University Hospital, Skejby

Aarhus, Jylland, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic HCV infection with genotype 1, 2, 3 or 4.
  • Age > 18 and <60
  • Liver biopsy or fibroscan performed within last 5 years
  • Signed informed consent form.

Exclusion criteria

  • Liver biopsy showing liver pathology not due to HCV infection.
  • Liver cirrhosis or severe liver fibrosis
  • Former antiviral HCV treatment (for included HCV patients).
  • HIV and/or Hepatitis B virus infection.
  • Alcohol or drug abuse within the last 2 years.
  • Neutropenia, anemia or thrombocytopenia.
  • Clinical signs of non-compensated liver pathology.
  • Moderate to severe cardiopulmonary disease (NYHA score 1 or above)
  • Creatinine clearance < 80mL/min.
  • Pregnancy.
  • Ferromagnetic implants
  • Significant somatic disease affecting the central nervous system (somatic/neurologic disease)
  • Head trauma resulting in unconsciousness > 5min
  • Schizophrenia or other psychotic disorders

Treatment and study plan

Interferon and ribavirin

Drug

Interferon 180 microgram weekly s.c. and ribavirin (800/100/1200 mg daily) p.o.

Other names: Pegasys (ATC Code: L03AB11) and Copegus (ATC Code: J05AB04)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Interferon-induced depression

    Time frame: 8-12 weeks after treatment inititation

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Study of Cerebral Function in Patients With Chronic Hepatitis C Infection Before and After Pegylated Interferon Alfa-2a and Ribavirin Therapy

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 11, 2008
Registry last updated
Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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