NCT04139941 is a clinical trial of Test for HCV antibodies with an RDT in Hepatitis C Virus Infection, sponsored by Foundation for Innovative New Diagnostics, Switzerland.

Who is sponsoring NCT04139941?

NCT04139941 is sponsored by Foundation for Innovative New Diagnostics, Switzerland.

What drugs are being tested in NCT04139941?

Interventions in NCT04139941: Test for HCV antibodies with an RDT.

What condition does NCT04139941 study?

NCT04139941 studies Hepatitis C Virus Infection.

Is NCT04139941 still recruiting?

NCT04139941 is currently completed. Last updated 7 July 2020.

Last reviewed 2020-07-07 · How we verify

NCT04139941

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation Study of HCV RDTs in Fresh Samples

Completed Last updated 7 July 2020

What this trial tests

trial testing Test for HCV antibodies with an RDT in Hepatitis C Virus Infection in 1,540 participants. Completed in 31 March 2020.

Timeline

31 July 2019

Primary endpoint
31 December 2019

31 March 2020

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,540
Start date	31 July 2019
Primary completion	31 December 2019
Estimated completion	31 March 2020
Sites	2 locations across Georgia, Cambodia

Drugs / interventions tested

Test for HCV antibodies with an RDT

Conditions studied

Hepatitis C Virus Infection — all drugs for Hepatitis C Virus Infection →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

18 and older, any sex, with Hepatitis C Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective study.
Vetter BN, Ongarello S, Tyshkovskiy A, Alkhazashvili M, et al · · 2020 · cited 4× · PMID 33270716 · DOI 10.1371/journal.pone.0243040

Verify or expand the search:

Other recruiting trials for Hepatitis C Virus Infection

Currently open trials in the same condition.

NCT06870019 — Hepatitis C Tracker Study · NA · recruiting
NCT06463912 — Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia · recruiting
NCT06718530 — Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Canc · recruiting
NCT06155006 — Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia · recruiting
NCT06431945 — Early Detection of HCV in Injection Drug Users · recruiting

Other Foundation for Innovative New Diagnostics, Switzerland trials

Trials by the same sponsor.

NCT06213051 — Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection · unknown
NCT05944731 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya. · NA · unknown
NCT06118749 — Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study · terminated
NCT05944718 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa · NA · completed
NCT06170515 — BGM and HbA1c POC Device Evaluation · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04139941 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Foundation for Innovative New Diagnostics, Switzerland
Last refreshed: 7 July 2020

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/NCT04139941.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing