Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- The participant and/or their parent/Legally Authorized Representative is willing and
able to provide signed informed consent or assent as appropriate
- Male or female adults 18 to 80 years of age, or adolescents 12 to 17 years of age
- Patients dependent on parenteral nutrition (PN) that receive PN for an average ≥ 4
days a week for 10 weeks or longer prior to screening to meet nutritional, caloric,
fluid, and/or electrolyte needs
- The Investigator expects no changes in the lipid, dextrose, amino acid, or vitamin
regimen to be medically necessary during the participant's participation in the study
- Willingness of participant to maintain his/her current habitual oral diet and fluids
regimen for the study duration
Exclusion Criteria:
- Participants taking steatogenic medications for ≥12 weeks in the past 12 months (e.g.,
amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids,
over the usual dose of estrogen for hormone replacement therapy, and valproate); those
taking any medicine (e.g., metformin, thiazolidinediones, ursodeoxycholic acid,
pentoxifylline, S-adenosyl-L-Methionine, and betaine) that could affect the
measurement of IFALD within 12 weeks prior to study entry
- Participants taking potential hepatotoxic medications that in the judgement of the
Investigator is causing hepatic abnormalities
- Participants with a cardiac pacemaker, intravascular stents, other metallic devices,
and claustrophobia which are contraindicated to magnetic resonance imaging
- Participants who took choline supplements or choline-containing multivitamins within
14 days of screening
- History of major organ transplant (e.g., heart, kidney, liver, etc.)
For more information on eligibility criteria, please contact the sponsor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.