NCT06623058

Accupower ® HCV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: CerbaXpert · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 2017/746). 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 and/or 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 fetomaternal.(2) The hepatitis C virus (HCV) was discovered in 1989.(3) It is an RNA virus that belongs to the family Flaviviridae.(4) 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 treatment.(6) Detection/quantification 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 IU/ml and Log IU/ml. (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 technique.(7) 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 Existation™FA 96/384 on serum and plasma of affected patients hepatitis C.

Conditions

• HEPATITIS C (HCV)

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-31
• Completion: 2025-05-30
• First posted: 2024-10-02
• Last updated: 2024-10-03

Locations

1 site across 1 country: France