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Table 3 BAT117213 study: schedule of procedures and data collection

From: BAT117213: Ileal bile acid transporter (IBAT) inhibition as a treatment for pruritus in primary biliary cirrhosis: study protocol for a randomised controlled trial

Period description Screening Placebo run-in Treatment period 1 Treatment period 2 Follow-upf
Day (relative to Day 1) -45 to-1 days 1 2–12 13 14 15 16–26 27 28 29 30–40 41 42 43 44 45–55 56
Admission to Unit     X     X     X      
Discharge       X     X     X    
Outpatient visit X X                X
Screening assessmentsa X                 
Brief Physical   X                X
12-lead ECGb X X    X     X     X     X
Vital signs X X    X     X     X     X
Urine drug/alcohol screen X X   X     X     X      X
β-hcg (women) X X   X     X     X      X
standard blood tests and urinalysis X     X     X     X     X
Randomisation X                 
Study treatment dosing   X X X X X X X X X X X X X X X  
Concomitant medication review   X   X     X     X      X
Meal served     X X X   X X X   X X X    
Blood samplesc      X     X     X     
Metabonomics (Stool and urine)     <-------------------->   <-------------------->   <----------------->    
Microbiomics (Stool)     <-------------------->   <-------------------->   <----------------->    
PBC-40 questionnaired   X   X     X     X      X
GSRSd   X   X     X     X      X
5-D Itch scaled   X   X     X     X      X
Faecal Occult blood X     X     X     X     X
Pruritus 0–10 point scale (electronic diary)e   <--------------------------------------------------------------------->
AE assessment   <--------------------------------------------------------------------->
PGx For subjects who consent only. Collect one PGx sample after the start of dosing, preferably on day 1
Exit interview                  X
  1. aScreening assessments: informed consent for the study and PGX; demographics; complete physical; medical/medication/drug/alcohol history; Hepatitis B and Hepatitis C screen
  2. bSingle ECG to be performed, with the exception of screening and day 14 when this will be in triplicate
  3. cBlood samples for GSK2330672, UDCA, bile acids, bile acid species, C4, Autotaxin, FGF19 and metabonomics
  4. dpatient reported outcome (PRO) assessments. On days in which PRO assessments are administered at study visits they should be administered before any other study procedure
  5. esymptoms recorded twice daily (pre-dose of study drug)
  6. fRescue treatment with antipruritic agents can be instituted in subjects with severe itching during the placebo follow up period