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Outcomes of Pre-Screening Analysis for Non-Alcoholic Steatohepatitis (NASH) Subjects in a Large Clinical Research Center

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Tampa

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Dr. Guy Neff

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A primary obstacle within NASH clinical trials is the low randomization rates. The prescreening process is often minimized and creates low level of screening confidence. For most screening protocols, research subjects undergo three screening steps: 1) laboratory analysis, 2) MRI sequencing, and then 3) liver biopsy confirmation. We decided to investigate possible changes to our prescreening criteria in hopes of improving our randomization rates. Our prescreening criteria prior to December 2020 required AST values >20, various kPa values, and CAP score (Controlled Attenuation Parameter) of 280 or above. To reach our goal of higher randomization success, in December 2020 we changed the three criteria components: AST values >30, kPa values > 8.5, and CAP scores over 300. The hypothesis is to evaluate prescreening protocol improvements in the screening protocol that will result in higher randomization rates by altering our prescreening criteria.

A retrospective multivariant analysis was completed evaluating randomized patients. Data collected includes the following: demographics, medical history for metabolic risk factors such as diabetes, BMI, waist circumference, hypertension, hyperlipidemia, and obesity, comprehensive serology including various laboratory values such as AST, MRI sequencing data, and liver biopsy outcomes. The prescreening protocol data collected prior to, and following December 2020 were compared.

The data set includes 50 randomized patients from March 2020 to June 2021. The prescreening protocol change occurred December 2020. Demographics prior to December showed 56.8% male randomization rate compared to 61.5% after December. Female demographics show 43.2% prior to December and 38.5% after December. Male age ranged 25 to 83 years (mean 59 years). Female age ranged from 35 to 82 year (mean 66 years). After adjusting the screening criteria, an increase in the NAS (NASH Activity Score) from a median of 5.0 (4-8) to a median of 6.0 (4-7) was noted. Success rates for the following steps prior to and after December 2020 are as follows: Step 1 (75% to 85%), Step 2 (75% to 77%), Step 3 (50% to 54%). The overall screen pass rate was approximately 38.6% prior to December and increased to 48% after December 2020.

The data above demonstrates that pathological analysis for NASH confirmation continues to remain variable leading to a higher screen fail rate. Adjusting AST to a higher value was beneficial, with no changes seen with the increase in CAP scores. Moving forward this data will benefit the NASH research disease state by identifying a more accurate prescreening criteria which will enhance clinical trial randomization efficiency.

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Outcomes of Pre-Screening Analysis for Non-Alcoholic Steatohepatitis (NASH) Subjects in a Large Clinical Research Center

A primary obstacle within NASH clinical trials is the low randomization rates. The prescreening process is often minimized and creates low level of screening confidence. For most screening protocols, research subjects undergo three screening steps: 1) laboratory analysis, 2) MRI sequencing, and then 3) liver biopsy confirmation. We decided to investigate possible changes to our prescreening criteria in hopes of improving our randomization rates. Our prescreening criteria prior to December 2020 required AST values >20, various kPa values, and CAP score (Controlled Attenuation Parameter) of 280 or above. To reach our goal of higher randomization success, in December 2020 we changed the three criteria components: AST values >30, kPa values > 8.5, and CAP scores over 300. The hypothesis is to evaluate prescreening protocol improvements in the screening protocol that will result in higher randomization rates by altering our prescreening criteria.

A retrospective multivariant analysis was completed evaluating randomized patients. Data collected includes the following: demographics, medical history for metabolic risk factors such as diabetes, BMI, waist circumference, hypertension, hyperlipidemia, and obesity, comprehensive serology including various laboratory values such as AST, MRI sequencing data, and liver biopsy outcomes. The prescreening protocol data collected prior to, and following December 2020 were compared.

The data set includes 50 randomized patients from March 2020 to June 2021. The prescreening protocol change occurred December 2020. Demographics prior to December showed 56.8% male randomization rate compared to 61.5% after December. Female demographics show 43.2% prior to December and 38.5% after December. Male age ranged 25 to 83 years (mean 59 years). Female age ranged from 35 to 82 year (mean 66 years). After adjusting the screening criteria, an increase in the NAS (NASH Activity Score) from a median of 5.0 (4-8) to a median of 6.0 (4-7) was noted. Success rates for the following steps prior to and after December 2020 are as follows: Step 1 (75% to 85%), Step 2 (75% to 77%), Step 3 (50% to 54%). The overall screen pass rate was approximately 38.6% prior to December and increased to 48% after December 2020.

The data above demonstrates that pathological analysis for NASH confirmation continues to remain variable leading to a higher screen fail rate. Adjusting AST to a higher value was beneficial, with no changes seen with the increase in CAP scores. Moving forward this data will benefit the NASH research disease state by identifying a more accurate prescreening criteria which will enhance clinical trial randomization efficiency.