Research & Development
A significant amount of research data has been compiled to support the potential utility of HepQuant liver function tests in the assessment of liver disease. To see the peer-reviewed published results of the QLFT study of the HALT-C Trial, see our Research Publications page.
Contact us if you would like more information on past and current studies that include the HepQuant liver function test.
HQ-US-SHUNT-1801 | The SHUNT-V Study
HepQuant LLC initiated its pivotal study, HQ-US-SHUNT-1801, “The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study” in the first quarter of 2019. The study is registered at the ClinicalTrials.gov website, and was conducted under FDA-issued IDE #G180098/S002. About 30 clinical testing sites participated in the study. An interim analysis of the data occurred in late 2020; data analysis, publication of results, and submission of PMA will follow. Subject to unanticipated hurdles related to FDA review, the expected launch of the HepQuant SHUNT Liver Diagnostic Kit is the 1st quarter of 2023.
One of the largest Hep-C research trials, the NIDDK-sponsored Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial was a randomized controlled trial designed to evaluate the safety and efficacy of long-term use of pegylated interferon for the treatment of chronic hepatitis C in patients who failed to respond to previous interferon therapy. The purpose of the HALT-C study was unrelated to the Company’s products; however, the trial provided a significant study population and a data set for the ancillary study of Quantitative Liver Function Tests (QLFTs), and in particular, the HepQuant tests. A subgroup of 285 patients from the HALT-C trial was studied with a battery of QLFT’s. The aim of the QLFT study was to define hepatic impairment using the prototypes of the HepQuant tests and correlate results with disease severity in patients with chronic hepatitis C. Tests and procedures included:
- Endoscopy at baseline, month 24, and month 48 provided data on varices and size of varices over time.
- Liver Biopsy at screening, month 24, and month 48 provided data on fibrosis and cirrhosis over time.
- Patient follow-up provided data on future clinical outcomes
- Learn more about the HALT-C Study