HEPATITIS C (HCV)BIOPERF-HCVNCT06623058
Accupower ® HCV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
An observational study of HEPATITIS C (HCV), run by CerbaXpert at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEPATITIS C (HCV)
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Infected patients with hepatitis C virus
Who may be able to join
- The patient to be included in this study must be able to understand the purpose of the research, in order to to give free and informed consent.
- Subject aged over 18
- Subject presenting at the investigation center and meeting one of these two criteria:
- Subject presenting with a prescription for HCV viral load determination
- Subject whose HCV infection is previously confirmed by CE marked tests.
- Subject capable of understanding the purpose of the research having given express free and informed consent
- Subject affiliated to or beneficiary of a social security system
Who cannot join
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative Subject participating in a clinical study/receiving investigational treatment
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Cerba Xpert
Frépillon, Île-de-France Region, 95000
Sabrina Kali, Dr., 33762376831, skali@cerbaresearch.com
About this study
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.
Read the 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)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infected patients with hepatitis C virus | Infected patients with hepatitis C virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commutability between serum and plasma hepatitis C viral load results with the ACCUPOWER HCV Quant Kit Bioneer Existation™FA 96/384.
The submitted protocol is carried out as part of a 'commutability' study, that is to say for Compare two matrix types on the Accupower ® HCV Quant Kit Bioneer Existence™FA 96/384. Indeed, for these two matrices to be claimed in the IFU of the kit it is necessary to prove that the two matrices give the same result.
The planned size of the evaluable cohort is 45 patients included over a period of 4 month. This size is justified by the recommendations of the applicable CLSI EP09 guide.
This guide details the use of several mathematical models that guarantee robust analysis even on a small cohort size. The operating methodology of the results is detailed below, taken from the recommendations of the CLSI EP09 guide
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS C (HCV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Collaborators
- BIONEER Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623058
- Sponsor's protocol ID
- 2024-A01285-42
- Other IDs
- 2024-A01285-42
- Acronym
- BIOPERF-HCV
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accupower ® HCV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
- ClinicalTrials.gov ID
- NCT06623058
- Acronym / sponsor ID
- BIOPERF-HCV / 2024-A01285-42
- Conditions
- HEPATITIS C (HCV)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Collaborators
- BIONEER Corporation
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infected patients with hepatitis C virus | – | –Infected patients with hepatitis C virus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Infected patients with hepatitis C virus
Key inclusion criteria (7 listed)
- The patient to be included in this study must be able to understand the purpose of the research, in order to to give free and informed consent.
- Subject aged over 18
- Subject presenting at the investigation center and meeting one of these two criteria:
- Subject capable of understanding the purpose of the research having given express free and informed consent
- Subject affiliated to or beneficiary of a social security system
Key exclusion criteria (2 listed)
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative Subject participating in a clinical study/receiving investigational treatment
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Commutability between serum and plasma hepatitis C viral load results with the ACCUPOWER HCV Quant Kit Bioneer Existation™FA 96/384.
Time frame: 4 months
The submitted protocol is carried out as part of a 'commutability' study, that is to say for Compare two matrix types on the Accupower ® HCV Quant Kit Bioneer Existence™FA 96/384. Indeed, for these two matrices to be claimed in the IFU of the kit it is necessary to prove that the two matrices give the same result. The planned size of the evaluable cohort is 45 patients included over a period of 4 month. This size is justified by the recommendations of the applicable CLSI EP09 guide. This guide details the use of several mathematical models that guarantee robust analysis even on a small cohort size. The operating methodology of the results is detailed below, taken from the recommendations of the CLSI EP09 guide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HEPATITIS C (HCV), run by CerbaXpert at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Kali, Dr (33762376831, skali@cerbaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Commutability between serum and plasma hepatitis C viral load results with the ACCUPOWER HCV Quant Kit Bioneer Existation™FA 96/384. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.