A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)

Inclusion Criteria

• •1. The participant is Japanese male or female with a body weight \>=3.0 kilograms (kg) and who is \>=1 month of age at the time of informed consent.
• •2. The participant is diagnosed with ALGS.
• •3. The participant has one or more of the following evidences of cholestasis:
• •1. Total serum bile acid (sBA) \>3\^ upper limit of the normal range (ULN) for age.
• •2. Direct bilirubin (conjugated) \>1 mg/dL.
• •3. Lipid soluble vitamin (LSV) deficiency otherwise unexplainable.
• •4. Gamma-glutamyl transferase (GGT) \>3\^ ULN for age.
• •5. Intractable pruritus explainable only by liver disease.
• •4. The participant is expected to have a consistent caregiver(s) for the duration of the study.
• •5. The participant has an access to phone for scheduled calls from study site.
• •6. Both a caregiver and participant above the age of assent are capable of reading and understanding the questionnaires.
• •7. Caregivers (and age-appropriate participants) must be willing and able to use an eDiary device during the study.
• •8. Caregivers (and age-appropriate participants) must complete at least 10 eDiary reports (morning or evening) during each of 2 consecutive weeks of the screening period (maximum possible reports=14 per week), even if the participant is an adult (over 18 years old).
• •9. Average daily score \>2 on the ItchRO questionnaire (maximum possible daily score of 4) for 2 consecutive weeks in the screening period, prior to dosing. A daily score is the higher of the scores for the morning and evening ItchRO. The average daily score is the sum of all daily scores divided by the number of days the ItchRO was completed. Since it is difficult to evaluate pruritus in infants, participants \<12 months of age at screening whose pruritus is unavoidably difficult to be evaluated are not necessarily required to meet the above score.