Status:
COMPLETED
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Schering-Plough
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Brief Summary
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00136214
Start Date
March 1 2004
End Date
March 1 2008
Last Update
July 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215