N/A
N=22
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00136214 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Jul 2018
Primary outcome: Primary: Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and Left Dorsolateral Prefrontal Cortex — 0.42; 0.30; 0.28; 0.28 ratio — p=0.08
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MR brain and neuropsychiatric tests (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and Left Dorsolateral Prefrontal Cortex |
0.42; 0.30; 0.28; 0.28; 0.34; NA | 0.08 |
| PRIMARY Neurocognitive Tests for Cerebral Function |
-1.43; -2.0; -0.78; -1.16; -0.7; NA | >0.05 |
Summary
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00136214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.