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Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

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Biogen

Status

Terminated

Conditions

Progressive Multifocal Leukoencephalopathy

Study type

Observational

Funder types

Industry

Identifiers

NCT01211639
101JC403

Details and patient eligibility

About

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).

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Subjects who have confirmed PML while on treatment with Natalizumab

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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