Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2005 by Beth Israel Deaconess Medical Center. Recruitment status was Recruiting

First Received on August 25, 2005. Last Updated on December 19, 2007 History of Changes

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	Schering-Plough
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00136214

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Estimated Enrollment:	26
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136214

Contacts

Contact: Valerie Byrnes, MD

617 632 1070

vbyrnes@bidmc.harvard.edu

Locations

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

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Schering-Plough

Investigators

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 21, 2012