TABLE 1.

Major inclusion/exclusion criteria for ITCH relative to LOGIC ALGS approach

ITCH (from Hep Comm. 2018;2:1184–98)	ALGS LOGIC natural history cohort
	Inclusion criteria
Diagnosis of ALGS	LOGIC definition of ALGS
Age 12 months–18 years inclusive	Age 12 months–18 years inclusive
Cholestasis	Cholestasis
Total serum bile acid > 3× ULN for age or	Total serum bile acids > 50 μM or
Direct bilirubin > 1 mg/dl or	Direct bilirubin or conjugated bilirubin > 1 mg/dl or
Fat soluble vitamin deficiency or	Not applied or
GGT > 3× ULN for age or	GGT > 150 IU/L or
Intractable pruritus based on liver disease	CSS score of 3 or 4
Pruritus—average daily ItchRO (observed) ≥ 2.0	CSS score ≥ 2.0
	Exclusion criteria
Chronic diarrhea requiring intravenous fluids	Not applied
Surgical interruption of the enterohepatic circulation	From LOGIC history for surgery
Liver transplant	From LOGIC history for surgery
ALT > 15× ULN	ALT > 600 insulin resistance/L at baseline
Decompensated cirrhosis	Decompensated cirrhosis
INR > 1.5 after vitamin K	Not applied—problem ascertaining vitamin K given
Albumin < 3.0 gr/dl	Albumin < 3.0 gr/dl
History of or presence of significant ascites	History of clinically evident ascites
History of variceal hemorrhage	History of gastrointestinal hemorrhage
History of encephalopathy	Not applied—not available
History of other liver disease	Reviewed historical date—excluded participants with prior Kasai hepatoportoenterostomy and diagnosis of biliary atresia
History of disease that could interfere with absorption of, e.g., drugs and bile acids, from intestine	Not applied—data unavailable but unlikely
Unable to complete study	Listed for liver transplant
Concomitant meds—cholestyramine or other resin, sodium phenylbutyrate, investigational agent trial	Applied as known
Nonadherence concern	Not applied

Abbreviations: GGT, gamma‐glutamyltransferase; INR, international normalized ratio.