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

Table 3 BAT117213 study: schedule of procedures and data collection

Period description	Screening	Placebo run-in				Treatment period 1				Treatment period 2				Follow-up^f
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 assessments^a	X
Brief Physical		X															X
12-lead ECG^b	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 samples^c					X				X				X
Metabonomics (Stool and urine)				<-------------------->				<-------------------->				<----------------->
Microbiomics (Stool)				<-------------------->				<-------------------->				<----------------->
PBC-40 questionnaire^d		X		X				X				X					X
GSRS^d		X		X				X				X					X
5-D Itch scale^d		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

^aScreening assessments: informed consent for the study and PGX; demographics; complete physical; medical/medication/drug/alcohol history; Hepatitis B and Hepatitis C screen
^bSingle ECG to be performed, with the exception of screening and day 14 when this will be in triplicate
^cBlood samples for GSK2330672, UDCA, bile acids, bile acid species, C4, Autotaxin, FGF19 and metabonomics
^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
^esymptoms recorded twice daily (pre-dose of study drug)
^fRescue treatment with antipruritic agents can be instituted in subjects with severe itching during the placebo follow up period

ISSN: 1471-230X