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Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

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: NCT01211639
Recruitment Status : Terminated (Due to lack of enrollment.)
First Posted : September 29, 2010
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date September 16, 2010
First Posted Date September 29, 2010
Last Update Posted Date January 19, 2015
Study Start Date October 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2010)
to examine host genetic variation and possible genetic susceptibility to PML [ Time Frame: Up to 3 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2010)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Official Title Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Brief Summary 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).
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood collection for genetic analysis Urine collection for archiving and future research use Plasma, Serum, and Peripheral Blood Mononuclear Cells (PBMC) collection for archiving and future research use
Sampling Method Non-Probability Sample
Study Population This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
Condition Progressive Multifocal Leukoencephalopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 15, 2015)
24
Original Estimated Enrollment
 (submitted: September 28, 2010)
50
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key Inclusion Criteria:

  • Subjects who have confirmed PML while on treatment with Natalizumab

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01211639
Other Study ID Numbers 101JC403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date January 2015