Trial Outcomes & Findings for The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology (NCT NCT03294941)

Results Overview

The baseline DSI, or disease severity index, is a measure of severity of liver disease at baseline. The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Baseline

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Overall Study STARTED	4	13
Overall Study COMPLETED	4	11
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study n=4 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study n=13 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	Total n=17 Participants Total of all reporting groups
Age, Continuous	48.75 years n=5 Participants	58.15 years n=7 Participants	55.94 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	13 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The baseline DSI, or disease severity index, is a measure of severity of liver disease at baseline. The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease).

Outcome measures

Outcome measures
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study n=4 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study n=13 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Baseline DSI	21.63 score on a scale Standard Deviation 3.31	20.93 score on a scale Standard Deviation 3.55

PRIMARY outcome

Timeframe: Baseline and at 48 weeks

Population: 15 subjects completed the week 48 SHUNT Test (4 in parallel study placebo group, and 11 in parallel study active study drug group), however, the SHUNT Test samples were unanalyzable for 1 subject on active study drug due to failure of the IV Clearance component of the SHUNT Test. Therefore, the present analysis only includes 14 subjects (4 on placebo, 10 on active study drug).

Improvement or worsening of liver disease severity from baseline to the week 48 visit as measured by the change in the disease severity index (DSI) (DSI at 48 weeks minus DSI at baseline). The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease).

Outcome measures

Outcome measures
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study n=4 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study n=10 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Change in DSI From Baseline to 48 Weeks	-1.08 score on a scale Standard Deviation 2.44	-1.00 score on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was conducted to compare DSI scores between Fibrosis categories instead of by placebo vs active study drug groups because the subject numbers were too low. There was only one subject in the placebo group with F4 Fibrosis. Additionally, this outcome measure was established to compare DSI scores to other liver disease severity scores regardless of study drug use, so this analysis was conducted by grouping fibrosis scores.

Compared baseline disease severity index (DSI) scores, which are used to measure severity of liver disease on a scale from 0 (healthy liver) to 50 (severe liver disease), between subjects with F3 or F4 Fibrosis at baseline. Fibrosis stages were obtained clinically using the NASH CRN Scoring System to grade liver biopsy results. This scoring system yields scores ranging from F0 (no fibrosis/healthiest) to F4 (cirrhosis/severe disease). Subjects in this study either had F3 Fibrosis (bridging fibrosis) or F4 Fibrosis (cirrhosis), so F3 subjects have less severe disease than F4 subjects.

Outcome measures

Outcome measures
Measure	HepQuant SHUNT Liver Diagnostic Kit - Placebo in Parallel Study n=9 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks	HepQuant SHUNT Liver Diagnostic Kit - Active Study Drug in Parallel Study n=8 Participants All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Severity of Liver Disease Index (DSI) Scores Stratified by Baseline NASH CRN Stage of Fibrosis	19.39 score on a scale Standard Deviation 1.70	23.02 score on a scale Standard Deviation 3.91

Adverse Events

HepQuant SHUNT Liver Diagnostic Kit

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HepQuant SHUNT Liver Diagnostic Kit n=17 participants at risk All subjects receive HepQuant SHUNT test and DSI measurement. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test HepQuant SHUNT Liver Diagnostic Kit: Serial testing over 48 weeks
Injury, poisoning and procedural complications Mild IV-related events	17.6% 3/17 • Number of events 3 • 12 months, from the date of enrollment through the 48 week/final study visit. Adverse events are all grouped together because the only intervention in the HepQuant Study is the HepQuant SHUNT Test. Although some analyses are conducted by grouping subjects into those who took the placebo in the parallel drug study versus those who were on active study drug in the parallel study, the HepQuant study itself had only one arm.

Additional Information

Elyse Handley

HepQuant, LLC

Phone: 303-923-2109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place