Clareo Health | Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Male or female 12 years of age or older at the time of signing the informed consent
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry
Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week
Females of childbearing potential must have a negative urine pregnancy test at screening
You may not be if
Participants taking steatogenic medications or any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to signing consent
Evidence of systemic active infection at the time of dosing
Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study
Participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study
Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)
Clinically significant renal disease
Low B12 or low serum folic acid levels that are less than the normal range
Participants with severe hepatic impairment, defined as Child-Turcotte-Pugh (CTP) Class C (score ≥10) at screening.
