Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

Completed

Conditions studied: Hepatitis C

In brief

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

Key facts

Study ID

NCT00136214

Run by

Beth Israel Deaconess Medical Center

People needed

22

Starts

2004-03-01

Expected to finish

2008-03-01

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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