NCT06910943Phase 2, phase 3Recruiting

Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2028-03Estimated

Enrollment · participants129Estimated

Source updated2026-08-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-08-24 · 1 field changed

Primary completion date changed

− Before

~~Jun 2027~~

+ After

Mar 2028

Check registry source

Posted 2025-10-24 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

Check registry source

Study details

Conditions studied

Choline Deficiency; Liver Injury

Treatments or interventions studied

Choline Chloride for InjectionDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Open-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 Visits; description: Cmax = maximum concentration; timeFrame: Week 1 to Week 8; measure: Open-Label Dose-Selection Phase: Open-Label Dose-Selection Phase: PK of plasma free choline (Tmax) during Week 1 and Week 8 Visits; description: Tmax = time of maximum concentration; timeFrame: Week 1 to Week 8; measure: Open-Label Dose-Selection Phase: PK of plasma free choline (AUC(0-TAU)) during Week 1 and Week 8 Visits; description: AUC = area under the curve, AUC(0-TAU) = AUC at end of dosing; timeFrame: Week 1 to Week 8; measure: Open-Label Dose-Selection Phase: Change from Baseline in plasma free choline concentrations at Week 8; timeFrame: Week 1 to Week 8; measure: Open-Label Dose-Selection Phase and Double-Blind, Placebo-Controlled Phase, Open-Label Extension Phase: Incidence and severity of TEAEs Incidence of TESAEs; description: TEAE = treatment emergent adverse event, TESAE = treatment emergent serious adverse event; timeFrame: Week 1 to Week 64; measure: Double-Blind, Placebo-Controlled Phase: Change from Baseline in peak plasma free choline concentrations (Cmax) at Week 8 in participants receiving Choline Chloride for Injection versus Placebo; description: Tmax = time of maximum concentration; timeFrame: Week 1 to Week 8; measure: Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Percentage of participants with plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 64; timeFrame: Week 64; measure: Open-Label Extension Phase: Percentage of participants maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8 and Week 64 (ie, both timepoints); timeFrame: Week 8 to Week 64; measure: Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % with plasma free choline concentrations of ≥9.5 nmol/mL at Week 64; timeFrame: Week 1 to Week 64; measure: Open-Label Extension Phase: Participants from Double-Blind Placebo-Controlled Phase: % maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8, Week 24 and Week 64 for participants who previously received Choline Chloride for Injection; timeFrame: Week 8 to Week 64

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history