Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Recruitment status was Recruiting
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Purpose
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
| Condition |
|---|
|
Hepatitis C |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects |
| Estimated Enrollment: | 26 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Valerie Byrnes, MD | 617 632 1070 | vbyrnes@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Valerie Byrnes, MD 617-632-1070 vbyrnes@bidmc.harvard.edu | |
| Principal Investigator: Nezam Afdhal, MD | |
| Principal Investigator: | Nezam Afdhal, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00136214 History of Changes |
| Other Study ID Numbers: | 2003P-000341 |
| Study First Received: | August 25, 2005 |
| Last Updated: | December 19, 2007 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013