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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient testing in patients with liver disease.
The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer, noninvasive, cost-effective, and well tolerated by patients. This study will compare the HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive patients with various etiologies of liver disease who have undergone technically successful HVPG testing as standard of care will also undergo HQ-SHUNT testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (HVPG) and HepQuant-SHUNT (HQ-Shunt) | Other | Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test. Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes |
| Results of HepQuant SHUNT Test: Systemic Clearance | Compare 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) | Up to 90 minutes |
| Results of HepQuant SHUNT Test: Apparent Portal Clearance | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes |
| Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes |
| Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes |
| Results of HepQuant SHUNT Test: SHUNT | Compare 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Wieland, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver (Leprino Building) | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22030902 | Result | Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2015 |
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| Hepatic Venous Pressure Gradient (HVPG) | Device | Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease |
|
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| Up to 90 minutes |
| Results of HepQuant SHUNT Test: DSI Score | Compare 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. | Up to 90 minutes |
| Results of HepQuant SHUNT Test: STAT | Compare 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. | 60 minutes |
| Immediately post HepQuant SHUNT test (Baseline up to Day 60) |
| Hours for Test | Number of hours it took for subjects to complete each test | Baseline, up to Day 60 |
| Received HVPG |
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| Received HQ Shunt |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HepQuant-SHUNT (HQ-Shunt) | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| Etiology of Liver Disease | Count of Participants | Participants |
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| Fibrosis Stage | Fibrosis stage indicates the severity of scarring of the liver. Possible grades range from F0 to F4, with F0 indicating no scarring and F4 indicating the most severe scarring. | Count of Participants | Participants |
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| Steatosis Grade | Count of Participants | Participants |
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| Co-Morbid Conditions | Number | participants |
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| Standard Laboratory Tests: Serum Sodium | Mean | Standard Deviation | mEq/L |
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| Standard Laboratory Tests: Creatine, Glucose and Bilirubin | Mean | Standard Deviation | mg/dL |
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| Standard Laboratory Tests: AST, Alkaline Phosphatase, ALT | Mean | Standard Deviation | IU/L |
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| Standard Laboratory Tests: Albumin | Mean | Standard Deviation | g/L |
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| Standard Laboratory Tests: WBC, RBC and Platelets | Mean | Standard Deviation | count/nL |
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| Standard Laboratory Tests: Hemoglobin | Mean | Standard Deviation | g/dL |
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| Standard Laboratory Tests: Hematocrit | Mean | Standard Deviation | % |
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| Standard Laboratory Tests: INR | Mean | Standard Deviation | No units (ratio) |
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| Standard Laboratory Tests: MELD Score | Model For End-Stage Liver Disease (MELD) scores range from 6 to 40, and is a measure of how severe a patient's liver disease is. Higher scores represent more severe liver disease and a worse outcome. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Standard Laboratory Tests: Child-Turcotte-Pugh (CTP) Score | The Child-Turcotte-Pugh (CTP) score measures cirrhosis severity. Scores range from 5-15, with higher scores indicating more severe cirrhosis and a worse outcome. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Posted | Mean | Standard Deviation | min-1 | Up to 90 minutes |
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| Primary | Results of HepQuant SHUNT Test: Systemic Clearance | Compare 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) | Posted | Mean | Standard Deviation | (13C-CA; ml min-1) | Up to 90 minutes |
|
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| Primary | Results of HepQuant SHUNT Test: Apparent Portal Clearance | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Posted | Mean | Standard Deviation | d4-CA; ml min-1 | Up to 90 minutes |
|
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| Primary | Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Posted | Mean | Standard Deviation | ml min-1 kg-1 | Up to 90 minutes |
|
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| Primary | Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Posted | Mean | Standard Deviation | ml min-1 kg-1 | Up to 90 minutes |
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| Primary | Results of HepQuant SHUNT Test: SHUNT | Compare 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 | Posted | Mean | Standard Deviation | percentage | Up to 90 minutes |
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| Primary | Results of HepQuant SHUNT Test: DSI Score | Compare 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. | Posted | Mean | Standard Deviation | score on a scale (DSI Score) | Up to 90 minutes |
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| Secondary | Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures. | 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 | subjects that underwent HVPG and HQ-Shunt completed surveys | Posted | Mean | Standard Deviation | units on a scale | Immediately post HepQuant SHUNT test (Baseline up to Day 60) |
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| Secondary | Hours for Test | Number of hours it took for subjects to complete each test | Number of hours | Posted | Number | participants | Baseline, up to Day 60 |
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| Primary | Results of HepQuant SHUNT Test: STAT | Compare 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. | Posted | Mean | Standard Deviation | uM/min | 60 minutes |
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6 Weeks
no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hepatic Venous Pressure Gradient (HVPG) | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | HepQuant-SHUNT (HQ-Shunt) | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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Study did not reach enrollment goal of 110, therefore analysis was limited due to low power
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Wieland | University of Colorado Denver | 720-848-2291 | amanda.wieland@cuanschutz.edu |
| Aug 26, 2020 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2017 | Jan 15, 2020 | ICF_000.pdf |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Unknown or Not Reported |
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| Autoimmune Hepatitis |
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| Wilsons Disease |
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| Budd-Chiari Syndrome |
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| Cryptogenic |
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| Other |
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| F2-F3 (F2.5) |
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| F3 |
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| F4 |
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| NA |
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| Moderate, 33 to 66% |
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| Severe, >66% |
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| NA |
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| Hypertension |
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| Dyslipidemia |
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| Gout |
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| Extrahepatic autoimmune disease |
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| Pulmonary hypertension |
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| Malignancy |
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| Bilirubin |
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| ALT |
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| Platelets |
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| Units | Counts |
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| Participants |
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