Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT03123159
Status:
TERMINATED
Last Update Posted:
2018-07-12
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance Evaluation of DxN HBV Assay
Sponsor:
Beckman Coulter, Inc.
Organization:
Study Overview
Official Title:
Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.
Detailed Description:
Same as brief summary.
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?:
True
Is an FDA AA801 Violation?: