Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

NCT00136214 | Completed Results

• 1 other identifier: 2003P000341
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

• Neurocognitive Tests for Cerebral Function

  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.

  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

Study Arms (2)

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

Interventions

MR brain and neuropsychiatric tests DIAGNOSTIC_TEST

Interferon Treated Group; Non-treated cohort control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Schering-Plough: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Byrnes V, Miller A, Lowry D, Hill E, Weinstein C, Alsop D, Lenkinski R, Afdhal NH. Effects of anti-viral therapy and HCV clearance on cerebral metabolism and cognition. J Hepatol. 2012 Mar;56(3):549-56. doi: 10.1016/j.jhep.2011.09.015. Epub 2011 Oct 23.

  PMID: 22027578 RESULT

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Nezam Afdhal
• Organization: BIDMC

nafdhal@bidmc.harvard.edu

617632118

Study Officials

• Nezam Afdhal, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Part-time

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: March 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)