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Dose-Selection, Safety and Efficacy Study with Open-Label Extension of Choline Chloride for Injection in Adolescent and Adult Patients with Intestinal Failure Receiving Long-Term Parenteral Support
EU CTIS ID: 2024-519496-26-00
What this study is testing
Dose-Selection (DS) 1. Description of PK parameters following treatment with Choline Chloride for Injection by rich PK sampling 2. To assess the safety of Choline Chloride for Injection Double-Blind (DB) 1. To demonstrate Choline Chloride for Injection as a source of choline at Week 8 2. Safety: To assess the safety of Choline Chloride for Injection versus Placebo Open-Label (OL) 1. To describe plasma free choline concentrations following treatment with Choline Chloride for Injection 2. Safety: To assess the safety of Choline Chloride for Injection
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female 12 years of age or older at the time of signing the informed consent. Adolescent (12 to <18 year of age) participants will not be enrolled in Denmark, France, or Poland.
- 2. Individuals or their parents/legally authorized representatives (LARs) who have voluntarily given written informed consent and participants who provided assent (if applicable) after the nature of the study has been explained according to applicable requirements, prior to study entry. Parent(s)/LAR(s) may provide written consent if the participant is under the age of 18. Written assent from adolescents is applicable if required per local regulations.
- 3. 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 (ie, signing of ICF) and for the duration of the study • Receiving a stable amount of lipid emulsion, dextrose, amino acids at least 4 weeks prior to screening • Receiving B12 and folic acid
- 4. Females of childbearing potential must have a negative urine pregnancy test at screening
You likely can't join if
- 1. Participants taking steatogenic medications for ≥ 12 weeks in the past 12 months (eg, amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids, over the usual dose of estrogen for hormone replacement therapy, and valproate); those taking any medicine (eg, metformin, thiazolidinediones, ursodeoxycholic acid, pentoxifylline, S-adenosyl-L-Methionine, betaine, and resmetirom) that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry
- 9. Fulminant liver failure, with active bleeding and/or encephalopathy. “A CTP class C” would be acceptable if there was no active bleeding or encephalopathy impairing ability to give consent
- 11. Planned surgery during the study period (eg. bowel resection or fistula repair)
- 12. Concurrent or planned therapy which, in the opinion of the Investigator, interferes with the participant’s ability to complete participation in the study or produce evaluable data
- 13. Any reason which, in the opinion of the Principal Investigator (PI), would make participation in the study against the participant’s best interests
- 10. Participation in an interventional clinical study with drugs within 6 weeks prior to screening
See the full eligibility criteria
- 1. Male or female 12 years of age or older at the time of signing the informed consent. Adolescent (12 to <18 year of age) participants will not be enrolled in Denmark, France, or Poland.
- 2. Individuals or their parents/legally authorized representatives (LARs) who have voluntarily given written informed consent and participants who provided assent (if applicable) after the nature of the study has been explained according to applicable requirements, prior to study entry. Parent(s)/LAR(s) may provide written consent if the participant is under the age of 18. Written assent from adolescents is applicable if required per local regulations.
- 3. 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 (ie, signing of ICF) and for the duration of the study • Receiving a stable amount of lipid emulsion, dextrose, amino acids at least 4 weeks prior to screening • Receiving B12 and folic acid
- 4. Females of childbearing potential must have a negative urine pregnancy test at screening
- 1. Participants taking steatogenic medications for ≥ 12 weeks in the past 12 months (eg, amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids, over the usual dose of estrogen for hormone replacement therapy, and valproate); those taking any medicine (eg, metformin, thiazolidinediones, ursodeoxycholic acid, pentoxifylline, S-adenosyl-L-Methionine, betaine, and resmetirom) that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry
- 9. Fulminant liver failure, with active bleeding and/or encephalopathy. “A CTP class C” would be acceptable if there was no active bleeding or encephalopathy impairing ability to give consent
- 11. Planned surgery during the study period (eg. bowel resection or fistula repair)
- 12. Concurrent or planned therapy which, in the opinion of the Investigator, interferes with the participant’s ability to complete participation in the study or produce evaluable data
- 13. Any reason which, in the opinion of the Principal Investigator (PI), would make participation in the study against the participant’s best interests
- 10. Participation in an interventional clinical study with drugs within 6 weeks prior to screening
- 2. Evidence of systemic active infection at the time of dosing
- 3. Participants intending to take non-study intervention choline supplements or choline-containing multivitamins during the course of the study
- 4. 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
- 5. Women who are nursing, pregnant or intending to become pregnant during the study
- 6. Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)
- 7. Clinically significant renal disease (defined as estimated glomerular filtration rate [eGFR] ≤ 30 mL/min/1.73 m²)
- 8. Low B12 or low serum folic acid levels that are less than the normal range
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.