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NCT04971330: HCV-EU-10-18
Access Anti-HCV Assay European Union (EU) Clinical Trial Protocol
trial testing Access HCV in HCV in 7,901 participants. Completed in 30 March 2021.
30 March 2021
Quick facts
| Lead sponsor | Beckman Coulter, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 7,901 |
| Start date | 4 November 2019 |
| Primary completion | 30 March 2021 |
| Estimated completion | 30 March 2021 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Access HCV
Conditions studied
- HCV — all drugs for HCV →
Sponsor
Beckman Coulter, Inc.
Who can join
18 and older, any sex, with HCV. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study was the collection and testing of clinical samples to determine the clinical performance in terms of diagnostic accuracy measured by specificity and sensitivity of the Access anti-Hepatitis C Virus (anti-HCV) assay on the DxI 9000 Access Immunoassay Analyzer. The Design Input Document (DID) indicates performance requirements and minimum target enrollment numbers (based on those in the CTS) of blood donor, hospitalized patient and known HCV antibody (Ab) positive samples for novel anti-HCV assays. A secondary objective was to determine the false initial reactive rate (IRR) of the Access anti-HCV assay.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04971330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Beckman Coulter, Inc. trials
Trials by the same sponsor.
- NCT07217431 — Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study · completed
- NCT06624293 — Access BNP Clinical Enrollment Study · completed
- NCT06379061 — Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts · completed
- NCT06289868 — Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23) · completed
- NCT06257628 — MACE CDS Software Master Enrollment Protocol · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04971330 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beckman Coulter, Inc.
- Last refreshed: 21 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04971330.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing