Trial Outcomes & Findings for Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG) (NCT NCT02523196)
NCT ID: NCT02523196
Last Updated: 2021-08-09
Results Overview
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Up to 90 minutes
Results posted on
2021-08-09
Participant Flow
Subjects can be excluded if they do not complete the study visit within 60 days of the HVPG testing or if they test positive in a urine pregnancy test the day of the HQ-SHUNT test.
Participant milestones
| Measure |
Hepatic Venous Pressure Gradient (HVPG) and HepQuant-SHUNT (HQ
Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.
Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test.
Hepatic Venous Pressure Gradient (HVPG): Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
Received HVPG
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20
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Overall Study
Received HQ Shunt
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20
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Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Baseline characteristics by cohort
| Measure |
HepQuant-SHUNT (HQ-Shunt)
n=20 Participants
Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.
HepQuant-SHUNT: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease
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|---|---|
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Age, Continuous
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49.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Wihite
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0 Participants
n=5 Participants
|
|
Weight
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87.1 Kg
STANDARD_DEVIATION 19.7 • n=5 Participants
|
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Etiology of Liver Disease
NASH
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9 Participants
n=5 Participants
|
|
Etiology of Liver Disease
HCV
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4 Participants
n=5 Participants
|
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Etiology of Liver Disease
Autoimmune Hepatitis
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3 Participants
n=5 Participants
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Etiology of Liver Disease
Wilsons Disease
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1 Participants
n=5 Participants
|
|
Etiology of Liver Disease
Budd-Chiari Syndrome
|
1 Participants
n=5 Participants
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|
Etiology of Liver Disease
Cryptogenic
|
1 Participants
n=5 Participants
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|
Etiology of Liver Disease
Other
|
1 Participants
n=5 Participants
|
|
Fibrosis Stage
F0
|
2 Participants
n=5 Participants
|
|
Fibrosis Stage
F1
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6 Participants
n=5 Participants
|
|
Fibrosis Stage
F2-F3 (F2.5)
|
3 Participants
n=5 Participants
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|
Fibrosis Stage
F3
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3 Participants
n=5 Participants
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|
Fibrosis Stage
F4
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5 Participants
n=5 Participants
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|
Fibrosis Stage
NA
|
1 Participants
n=5 Participants
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|
Steatosis Grade
Mild, <5%
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4 Participants
n=5 Participants
|
|
Steatosis Grade
Mild, 5 to 33%
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9 Participants
n=5 Participants
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|
Steatosis Grade
Moderate, 33 to 66%
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4 Participants
n=5 Participants
|
|
Steatosis Grade
Severe, >66%
|
1 Participants
n=5 Participants
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|
Steatosis Grade
NA
|
2 Participants
n=5 Participants
|
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Co-Morbid Conditions
Obesity
|
10 participants
n=5 Participants
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Co-Morbid Conditions
Diabetes Mellitus
|
9 participants
n=5 Participants
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Co-Morbid Conditions
Hypertension
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8 participants
n=5 Participants
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Co-Morbid Conditions
Dyslipidemia
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4 participants
n=5 Participants
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Co-Morbid Conditions
Gout
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1 participants
n=5 Participants
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Co-Morbid Conditions
Extrahepatic autoimmune disease
|
7 participants
n=5 Participants
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Co-Morbid Conditions
Pulmonary hypertension
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1 participants
n=5 Participants
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Co-Morbid Conditions
Malignancy
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1 participants
n=5 Participants
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Standard Laboratory Tests: Serum Sodium
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136 mEq/L
STANDARD_DEVIATION 4 • n=5 Participants
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Standard Laboratory Tests: Creatine, Glucose and Bilirubin
Creatine
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0.71 mg/dL
STANDARD_DEVIATION 0.15 • n=5 Participants
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|
Standard Laboratory Tests: Creatine, Glucose and Bilirubin
Glucose
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149 mg/dL
STANDARD_DEVIATION 140 • n=5 Participants
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Standard Laboratory Tests: Creatine, Glucose and Bilirubin
Bilirubin
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0.75 mg/dL
STANDARD_DEVIATION 0.34 • n=5 Participants
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|
Standard Laboratory Tests: AST, Alkaline Phosphatase, ALT
AST
|
46 IU/L
STANDARD_DEVIATION 36 • n=5 Participants
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|
Standard Laboratory Tests: AST, Alkaline Phosphatase, ALT
Alkaline Phosphatase
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108 IU/L
STANDARD_DEVIATION 100 • n=5 Participants
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|
Standard Laboratory Tests: AST, Alkaline Phosphatase, ALT
ALT
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53 IU/L
STANDARD_DEVIATION 45 • n=5 Participants
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Standard Laboratory Tests: Albumin
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3.79 g/L
STANDARD_DEVIATION .49 • n=5 Participants
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Standard Laboratory Tests: WBC, RBC and Platelets
WBC
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7.22 count/nL
STANDARD_DEVIATION 3.06 • n=5 Participants
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Standard Laboratory Tests: WBC, RBC and Platelets
RBC
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4.44 count/nL
STANDARD_DEVIATION 0.84 • n=5 Participants
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Standard Laboratory Tests: WBC, RBC and Platelets
Platelets
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218.45 count/nL
STANDARD_DEVIATION 102.56 • n=5 Participants
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Standard Laboratory Tests: Hemoglobin
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13.38 g/dL
STANDARD_DEVIATION 2.91 • n=5 Participants
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Standard Laboratory Tests: Hematocrit
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39.60 %
STANDARD_DEVIATION 7.50 • n=5 Participants
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Standard Laboratory Tests: INR
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1.11 No units (ratio)
STANDARD_DEVIATION 0.14 • n=5 Participants
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Standard Laboratory Tests: MELD Score
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7.35 units on a scale
STANDARD_DEVIATION 1.84 • n=5 Participants
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Standard Laboratory Tests: Child-Turcotte-Pugh (CTP) Score
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5.35 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
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All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
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0.104 min-1
Standard Deviation 0.017
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0.092 min-1
Standard Deviation 0.023
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0.099 min-1
Standard Deviation 0.020
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. Systemic Clearance (13C-CA; ml min-1)
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
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All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: Systemic Clearance
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463 (13C-CA; ml min-1)
Standard Deviation 161
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384 (13C-CA; ml min-1)
Standard Deviation 137
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427 (13C-CA; ml min-1)
Standard Deviation 152
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
|
All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: Apparent Portal Clearance
|
1538 d4-CA; ml min-1
Standard Deviation 525
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975 d4-CA; ml min-1
Standard Deviation 464
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1285 d4-CA; ml min-1
Standard Deviation 564
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
|
All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
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5.30 ml min-1 kg-1
Standard Deviation 1.09
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4.47 ml min-1 kg-1
Standard Deviation 1.43
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4.92 ml min-1 kg-1
Standard Deviation 1.29
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
|
All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
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17.83 ml min-1 kg-1
Standard Deviation 6.37
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11.11 ml min-1 kg-1
Standard Deviation 5.24
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14.81 ml min-1 kg-1
Standard Deviation 6.69
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. SHUNT% is The percent of the oral dose of cholate that escapes hepatic extraction
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
|
All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: SHUNT
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29.08 percentage
Standard Deviation 9.89
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47.50 percentage
Standard Deviation 24.24
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37.37 percentage
Standard Deviation 19.68
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PRIMARY outcome
Timeframe: Up to 90 minutesCompare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. DSI range is from 0 to 50. 0 implies no disease; 50 implies severe end-stage disease.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
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All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: DSI Score
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14.64 score on a scale (DSI Score)
Standard Deviation 3.86
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20.68 score on a scale (DSI Score)
Standard Deviation 6.30
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17.36 score on a scale (DSI Score)
Standard Deviation 5.84
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PRIMARY outcome
Timeframe: 60 minutesCompare HepQuant STAT test from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. HepQuant STAT is a simple "drink and draw" blood-based clearance test that quantifies hepatic impairment from early through late stages of disease.
Outcome measures
| Measure |
HVPG <6 mmHg
n=11 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=9 Participants
Patients with portal hypertension
|
All Patients
n=20 Participants
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Results of HepQuant SHUNT Test: STAT
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0.61 uM/min
Standard Deviation 0.27
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1.29 uM/min
Standard Deviation 0.73
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0.92 uM/min
Standard Deviation 0.62
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SECONDARY outcome
Timeframe: Immediately post HepQuant SHUNT test (Baseline up to Day 60)Population: subjects that underwent HVPG and HQ-Shunt completed surveys
Overall experience and willingness to repeat 0-10 Scale 0 being no pain, 10 being severe pain 0 being no discomfort, 10 being severe discomfort 0 being no interference with daily life, 10 being unable to carry on activities 0 being very negative experience, 10 being very positive experience 0 being definitely not wanting to have the test again, 10 being very willing to have the test again
Outcome measures
| Measure |
HVPG <6 mmHg
n=20 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=20 Participants
Patients with portal hypertension
|
All Patients
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
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|---|---|---|---|
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Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Pain
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3.9 units on a scale
Standard Deviation 3.14
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.35 units on a scale
Standard Deviation .59
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—
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Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Discomfort
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4.2 units on a scale
Standard Deviation 2.89
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.5 units on a scale
Standard Deviation .89
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—
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Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Interfere with Daily Life
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5.9 units on a scale
Standard Deviation 3.14
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1.25 units on a scale
Standard Deviation 1.41
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—
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Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Overall Experience
|
6.2 units on a scale
Standard Deviation 2.73
|
9.6 units on a scale
Standard Deviation .68
|
—
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Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Willingness to Repeat
|
5.65 units on a scale
Standard Deviation 3.59
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9.85 units on a scale
Standard Deviation .37
|
—
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SECONDARY outcome
Timeframe: Baseline, up to Day 60Population: Number of hours
Number of hours it took for subjects to complete each test
Outcome measures
| Measure |
HVPG <6 mmHg
n=20 Participants
Patients without portal hypertension
|
HVPG ≥6 mmHg
n=20 Participants
Patients with portal hypertension
|
All Patients
patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension
|
|---|---|---|---|
|
Hours for Test
0-3 hours
|
4 participants
|
18 participants
|
—
|
|
Hours for Test
3-6 hours
|
5 participants
|
2 participants
|
—
|
|
Hours for Test
6-9 hours
|
3 participants
|
0 participants
|
—
|
|
Hours for Test
9-12 hours
|
8 participants
|
0 participants
|
—
|
Adverse Events
Hepatic Venous Pressure Gradient (HVPG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HepQuant-SHUNT (HQ-Shunt)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place