Table 1

Time and events schedule—PEARL trial

ProcedureScreeningDay 7
Day 3Day 0
Day 10W4W12W26W52
Window (days)max - 21±4±7±7±7±7±7
Eligibility assessments
Informed consentX
Inclusion/exclusion criteriaX
Medical history +concomitant medicationX
Study medicationEmbedded Image
Physical examination*XXXXXXX
Liver frailty indexXXX
Assessment of hepatic encephalopathy by West Haven criteriaXXXXXXX
Assessment of hepatic encephalopathy by PHES and S-ANT1XXXX
Assessment of quality of life†XXX
Economic evaluation questionnaires‡XXX
Assessment of adverse eventsXXXXXX
Assessment of compliance and concomitant medicationXXXXXX
Laboratory tests§XXXXXX
Storage of peripheral blood and/or portal (*) vein bloodX X*XX
Storage of stool sampleXXXX
Storage of saliva samplesXXXX
Radiological assessment and flow measurementXXXX
  • NB: Visit day 7 might be the same as the day of start study medication.

  • *Height and weight, vital signs, including pulse rate, blood pressure, respiration rate and temperature, signs of ascites or oedema.

  • †EQ-5D-5L questionnaire and LDSI 2.0 questionnaire.

  • ‡Adapted version of the Productivity Cost Questionnaire and Medical Consumption Questionnaire.

  • §Clinical chemistry: sodium, potassium, serum creatinine, glucose, alanine aminotransferase, aspartate aminotransferase, total and direct bilirubin, alkaline phosphatase, gamma-GT, C reactive protein, albumin, ammonia. Coagulation: international normalised ratio, PT. haematology: haematocrit, haemoglobin.

  • PHES, Psychometric Hepatic Encephalopathy Score; S-ANT1, simplified one min animal naming test.