An observational study in Progressive Multifocal Leukoencephalopathy, sponsored by Biogen. Terminated at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by Biogen · Observational
The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).
Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.
29 studies on the registry are indexed under Leukoencephalopathy, Progressive Multifocal; 7 are open to participants now.
This study's enrollment of 24 is below the median of 96 across 12 observational studies indexed under Leukoencephalopathy, Progressive Multifocal.
Browse Leukoencephalopathy, Progressive Multifocal studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
to examine host genetic variation and possible genetic susceptibility to PML
Time frame: Up to 3 Months
To explore predisposing factors of the innate and adaptive immune system
Time frame: Up to 3 Months
To analyze DNA sequences of JCV
Time frame: Up to 3 Months
optional substudy: to test alterations in DNA repair pathways
Time frame: Up to 3 Months
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Leukoencephalopathy, Progressive Multifocal →