Study to Assess Alcoholic Hepatitis with Multiparametric Magnetic Resonance Elastography

Overview

About this study

All 20 patients requiring a liver biopsy for inclusion in our clinical trials will undergo a hepatogram examination within 72 hours of screening and prior to randomization. Inclusion and exclusion criteria for patients are identical to that proposed in the associated clinical trials. In addition to the strict exclusion criteria addressed in RFA AA-18-002 and RFA AA-18-005, we will exclude patients with claustrophobia.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

We propose recruiting a total of 44 adult subjects including 20 AH patients for a cross-sectional observational study and 24 AH patients for a longitudinal treatment efficacy study.

All 20 patients requiring a liver biopsy for inclusion in our clinical trials will undergo a hepatogram examination within 72 hours of screening and prior to randomization. Inclusion and exclusion criteria for patients are identical to that proposed in the associated clinical trials. In addition to the strict exclusion criteria addressed in RFA AA-18-002 and RFA AA-18-005, we will exclude patients with claustrophobia.

Inclusion Criteria - Cross-Sectional Observational Study:

  • Have a history of heavy alcohol consumption (defined as > 60 grams per day on average in men, and > 40 grams in women for a minimum of 6 months) within the 60 days of entry into the study;
  • AST > 50 IU/l, AST/ALT ration > 1.5, but both less than 500 U/L; serum bilirubin > 3mg/dL;
  • MELD score 11-35;
  • Have liver biopsies (as clinical care for diagnostic uncertainty and possible confounding factors);
  • Men or women aged ≥ 21 years.

Exclusion Criteria - Cross-Sectional Observational Study:

  • Inability to provide consent;
  • Evidence of other liver diseases such as autoimmune hepatitis, ischemic, sepsis- or drug-induced;
  • Hepatocellular carcinoma or other malignancy disease current;
  • Pregnancy and breastfeeding;
  • Inability to undergo MR scanning due to claustrophobia.

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All 24 patients enrolled in this clinical trial addressed in RFA AA-18-005 of high MELD AH patients will undergo a hepatogram examination at baseline, 30 days and 90 days, independent of whether the patient drops out later (~25% dropout estimated). In addition to the strict exclusion criteria addressed in RFA AA-18-005, we will exclude patients with claustrophobia.

Inclusion Criteria - Longitudinal Treatment Efficacy Study:

  • History of heavy alcohol abuse use: the daily consumption > 60 grams for males, > 40 grams for females, for more than 6 months;
  • The consumption of alcohol within the 8 weeks of entry into the study;
  • Serum bilirubin > 3mg/dL; AST >ALT, but less than 500 U/L;
  • MELD score 21-28.

Exclusion Criteria - Longitudinal Treatment Efficacy Study:

  • Inability to provide consent;
  • Organ failure as defined by hepatic encephalopathy > stage 3; need for ventilation or vasopressor support; renal replacement therapy;
  • HCC or other malignancy current or treated;
  • Participant in another therapeutic AH study within previous 90 days;
  • MELD score < 21 or > 28;
  • Inability to undergo MR scanning due to claustrophobia.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Open for enrollment

Contact information:

Kevin Nelson B.S.

(507) 284-9295

Nelson.Kevin1@mayo.edu

More information

Publications

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Study Results Summary

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Supplemental Study Information

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