Research & Development
A significant amount of research data has been compiled to support the potential utility of HepQuant 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 HepQuant studies.
HQ-US-SHUNT-1801 | The SHUNT-V Study
After discussion with the FDA and modifications to study design, HepQuant LLC proceeded in 1st quarter 2019 with initiating its pivotal study, HQ-US-SHUNT-1801, “The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study”. The study is registered at the ClinicalTrials.gov website, the CRO is SYNEOS, and the FDA-issued IDE is #G180098/S002. About 30 clinical testing sites are actively enrolling subjects. An interim analysis of the data is scheduled for late 2020; data analysis, publication of results, and submission of PMA will follow. Subject to unanticipated hurdles related to rate of enrollment, study results, and FDA review, the expected launch of the HepQuant SHUNT Liver Diagnostic Kit is the 1st quarter of 2022.
One of the largest Hep-C research trials, the 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