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Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136214
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Nezam H. Afdhal, Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment
Hepatitis C Diagnostic Test: MR brain and neuropsychiatric tests

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.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects
Study Start Date : March 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Group/Cohort Intervention/treatment
Interferon Treated Group
Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests
Diagnostic Test: MR brain and neuropsychiatric tests
Non-treated cohort control
Group undergoing MR brain and neuropsychiatric tests
Diagnostic Test: MR brain and neuropsychiatric tests



Primary Outcome Measures :
  1. 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 [ Time Frame: 18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline ]
    Evaluation of changes in MR spectroscopy. reductions in ratio of Cho and MI reflect improvements in cerebral inflammation and improvement in cognition. Increases in the NAA ratio are suggestive of improvement in cognitive function.

  2. Neurocognitive Tests for Cerebral Function [ Time Frame: 18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline and only done in treated group and not controls ]
    A battery of pen and paper neurocognitive tests where subject means are reported compared to the normative Z score. Data is reported at baseline (T1), week 12 on treatment (T2) and 12 weeks after treatment (week 60, T3). Improvements are increases in the test result compared to baseline as determined against the Z score. tests performed included Hopkins learning trials (HVLT), a measure of of verbal learning and memory and the Roy-Osterrieth Complex figure test (ROCF) which evaluates visio-spatal abilities, memory, planning and working memory. Improvements in the score (increases in value compared, either less negative or more positive to the Z score) shown in the table are reflective of improvements in these neurocognitive parameters.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HCV positive patients Subjects with cirrhosis, active alcohol or drug abuse, co-infection with human immunodeficiency virus (HIV), structural brain abnormality, past history of cerebrovascular accident (CVA), serious head trauma, and seizure disorder were excluded. Other exclusions were contraindication to PIFN therapy, current psychiatric disorder or contraindications to MRI e.g., pacemaker and claustrophobia.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136214


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Schering-Plough
Investigators
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Principal Investigator: Nezam Afdhal, MD Beth Israel Deaconess Medical Center
Publications of Results:
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Responsible Party: Nezam H. Afdhal, Professor of Medicine, Part-time, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00136214    
Other Study ID Numbers: 2003P000341
First Posted: August 29, 2005    Key Record Dates
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections