Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623058
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Accupower HCV Performance Evaluation Quant Kit Bioneer ExistationFA 96384
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accupower HCV Performance Evaluation Quant Kit Bioneer ExistationFA 96384
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPERF-HCV
Brief Summary:
As part of the CE marking of a hepatitis C diagnostic kit the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR RE 2017746
Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients suffering from the virus hepatitis C and whose viral load is positive This prospective collection will be carried out in 4 laboratories of the Cerba Healthcare group
Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients suffering from the virus hepatitis C and whose viral load is positive This prospective collection will be carried out in 4 laboratories of the Cerba Healthcare group
Detailed Description:
Viral hepatitis are primarily human systemic infections caused by viruses hepatic diseases which cause damage to the liver by hepatocyte infection of the virus andor a host immune response to the virus 1 Hepatitis is grouped into five types A B C D E and is mainly transmitted by parenteral sexual and fetomaternal2 The hepatitis C virus HCV was discovered in 19893 It is an RNA virus that belongs to the family Flaviviridae4 Infection with the hepatitis C virus is characterized by clinical signs such as such as jaundice asthenia anorexia In approximately 30 15 to 45 of infected people the virus is spontaneously eliminated within six months following infection without any treatment 5 For the remaining 70 55 to 85 the infection will progress to a chronic form In patients chronic the risk of cirrhosis is 15 to 30 in the 20 years following infection 5 A assessment of liver damage and virus replication in the blood is made before starting treatment6 Detectionquantification of HCV RNA in serum or plasma must therefore be available before to initiate antiviral treatment HCV RNA must be tested for by a sensitive test giving a result viral load expressed in IUml and Log IUml 6 Monitoring of response to treatments is done also by the detection of viral RNA particularly at 12 weeks post-treatment where a viral load undetectable is a sign of effective treatment and healing 6 On the European market quantitative determination of hepatitis C viral load as part of Diagnosis and monitoring of the disease is done by real-time PCR which is the reference technique7 As part of routine care there are several diagnostic PCR kits that can be used on plasma or serum Today there are no CE approved PCR kits that allow the quantification of viral RNA at the both serum and plasma Our study will make it possible to evaluate the performance of the Bionner kit PCR kit ACCUPOWER Quant Kit Bioneer ExistationFA 96384 on serum and plasma of affected patients hepatitis C
Study Oversight
Has Oversight DMC:
None
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?:
None