Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT01804660
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population
Sponsor:
GeNeuro Innovation SAS
Organization:
Study Overview
Official Title:
A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTROL
Brief Summary:
This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: