Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136214
Recruitment Status : Unknown
Verified August 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
First Posted : August 29, 2005
Last Update Posted : December 24, 2007
Information provided by:
Beth Israel Deaconess Medical Center

Brief Summary:
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.

Condition or disease
Hepatitis C

Detailed Description:

Subjects with non-cirrhotic hepatitis C will have a magnetic resonance imaging (MRI)/magnetic resonance (MR) spectroscopy and neuropsychological testing prior to starting interferon. Subjects will have repeat testing following 12 weeks of interferon therapy and again at 12 weeks post interferon therapy.

MR spectroscopy (MRS) will measure the cerebral metabolites, NAA (N-acetyl aspartate), Cho (choline), MI (myoinositol) and Cr (creatine) at 3 distinct brain regions, i.e. basal ganglia and 2 locations within the frontal cortex.

Neuropsychological testing will include tests of the following cognitive domains: executive functioning, memory, language, motor skills and will also include questionnaires pertaining to quality of life (SF-36), mood (Beck's depression inventory) and a self-rating cognitive questionnaire (Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scales [CAARS]).

Control subjects will include non-cirrhotic HCV subjects who are not taking interferon therapy.

Study Type : Observational
Estimated Enrollment : 26 participants
Time Perspective: Prospective
Official Title: A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects
Study Start Date : March 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults (>18 years old) of both sexes with chronic HCV infection (all genotypes).
  • Subjects due to start treatment with pegylated interferon-alpha (IFN-a) for HCV eradication.
  • Subjects with chronic hepatitis C who have elected not to be treated with pegylated-IFN-a
  • Subjects with mild fibrosis on liver biopsy (stage 0-III/IV fibrosis)
  • Subjects able to give informed consent.
  • Subjects with controlled depression currently taking anti-depressant medication.

Exclusion Criteria:

  • Subjects with cirrhosis on liver biopsy.
  • Subjects with active alcohol or drug abuse.
  • Subjects co-infected with human immunodeficiency virus (HIV).
  • Subjects with structural brain abnormality, past history of cerebrovascular accident (CVA) or serious head trauma.
  • Subjects with seizure disorder.
  • Subjects with any contraindication to IFN therapy.
  • Subjects with a poor command of the English language.
  • Subjects with a contraindication to MRI, e.g. pacemaker, claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136214

Contact: Valerie Byrnes, MD 617 632 1070

United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Valerie Byrnes, MD    617-632-1070   
Principal Investigator: Nezam Afdhal, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Nezam Afdhal, MD Beth Israel Deaconess Medical Center Identifier: NCT00136214     History of Changes
Other Study ID Numbers: 2003P-000341
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: August 2005

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents