- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02508298
Surrogate Markers of Portal Pressure
Surrogate Markers of Portal Pressure and Changes in Portal Pressure in Patients With Compensated Cirrhosis Undergoing Anti-viral Therapy
Study Overview
Status
Conditions
Detailed Description
Subjects will be recruited from the outpatient setting of the West Haven VA Medical Center and the Yale Liver Clinic. Subjects between 18-85 years of age with compensated cirrhosis due to chronic hepatitis C virus (HCV) infection who will be starting anti-viral therapy to treat HCV within the next 3 months will be eligible for this study. 33 subjects (assuming 10% loss to follow-up) will be recruited and their participation will last from 6-12 months. The expected duration of the study is 2 years.
The primary end point of the study is to correlate the change (from baseline to after completing anti-HCV therapy) in ICG retention test, LS and SS as measured by ARFI with HVPG. After consent has been obtained, subjects will undergo ICG retention test, ARFI imaging and HVPG measurements before and after HCV therapy. Blood samples, demographic and clinical data will be collected before and after HCV therapy. Correlations between changes in HVPG and changes in ICG, LS and SS will be assessed. With 30 patients , we will have 80% power to perform a hypothesis test of the Pearson correlation assuming an observed correlation of 0.70 and a two-sided type I error rate of 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale-New Haven Hospital
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-85
- HCV infection (HCV-RNA positive)
- Compensated cirrhosis will be defined histologically and/or clinically (presence of compatible lab findings (platelet count ≤ 150,000, total bilirubin ≥ 2, serum albumin ≤ 3.5, INR ≥ 1.2) PLUS compatible physical exam features (cutaneous stigmata, gynecomastia in men, or splenomegaly) OR compatible radiological findings (nodular liver surface, splenomegaly, and/or collaterals). (The ultimate confirmation of the diagnosis of cirrhosis will be a baseline HVPG > 5 mmHg)
- Planned anti-HCV therapy in the next 3 months
Exclusion Criteria:
- Any clinically-evident complication of cirrhosis that defines decompensation : jaundice, ascites, variceal hemorrhage, overt hepatic encephalopathy)
- Hepatocellular carcinoma
- Co-infection with HBV or HIV
- Ongoing alcohol abuse
- Occlusive portal thrombosis,
- Presence of comorbid conditions conferring a life expectancy<1 year, history of allergy to iodides, pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Indocyanine green retention test
A baseline venous sample of 5 ml of venous will be drawn for pre-infusion measurement.
Under sterile conditions 0.5 mg/kg body weight of ICG will be injected into vein.
Further blood samples (5 ml each) will be collected at 5, 10, 15 and 20 minute intervals after the injection from a peripheral vein in the opposite arm using another intravenous catheter.
After serum is separated by centrifugation, optical densities will be measured at 804 nm using a calibrated method for measurement of ICG level s.
ICG retention at 15 minutes and elimination rate constant will be calculated by fitting the serum disappearance curve to a single exponential decay equation.This will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
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HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein.
Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO).
After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium.
Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.
Other Names:
As decribed in arm descriptions
Other Names:
|
Active Comparator: Liver stiffness measurement
ARFI measurements of the liver will be obtained using a standard ultrasound probe.
The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
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HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein.
Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO).
After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium.
Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.
Other Names:
As decribed in arm descriptions; perfromed by ARFI
Other Names:
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Active Comparator: Spleen stiffness measurement
ARFI measurements of the spleen will be obtained using a standard ultrasound probe.
The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
|
HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein.
Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO).
After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium.
Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.
Other Names:
As decribed in arm descriptions; performed by ARFI
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indocyanine Green before and after treatment of hepatitis c
Time Frame: 2 years
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Indocyanine Green will be obtained , this will be conducted before and after treatment for hepatitis c and is measured in mg/dl
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spleen stiffness before and after treatment of hepatitis c
Time Frame: 2 years
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Spleen stiffness will be obtained by ARFI, this will be conducted before and after treatment for hepatitis c and is measured in m/sec
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2 years
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Liver stiffness before and after treatment of hepatitis c
Time Frame: 2 years
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Liver stiffness will be obtained by ARFI, this will be conducted before and after treatment for hepatitis c and is measured in m/sec
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2 years
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Hepatic venous pressure gradient before and after treatment of hepatitis c
Time Frame: 2 years
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Hepatic venous pressure gradient would be obtained by catheterization of the hepatic vein, this will be conducted before and after treatment for hepatitis c and is measured in mmHg
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guadalupe Garcia-Tsao, MD, VA Connecticut Healthcare System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GGT0037
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