Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
← catalyst calendarNCT06910943 · readout ≤ 315 d
Sponsored by Protara Therapeutics (industry) · TARA — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
129estimated
Sites
17
Countries
Belgium, Denmark, France +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-10 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Choline Deficiency
- Liver Injury
Interventions
- Drug: Choline Chloride for Injection
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFOpen-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 Visits
measured Week 1 to Week 8
Open-Label Dose-Selection Phase: Open-Label Dose-Selection Phase: PK of plasma free choline (Tmax) during Week 1 and Week 8 Visits
measured Week 1 to Week 8
Open-Label Dose-Selection Phase: PK of plasma free choline (AUC(0-TAU)) during Week 1 and Week 8 Visits
measured Week 1 to Week 8
Open-Label Dose-Selection Phase: Change from Baseline in plasma free choline concentrations at Week 8
measured Week 1 to Week 8
Open-Label Dose-Selection Phase and Double-Blind, Placebo-Controlled Phase, Open-Label Extension Phase: Incidence and severity of TEAEs Incidence of TESAEs
measured Week 1 to Week 64
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
measured Week 1 to Week 8
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
measured Week 64
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)
measured Week 8 to Week 64
Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % with plasma free choline concentrations of ≥9.5 nmol/mL at Week 64
measured Week 1 to Week 64
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
measured Week 8 to Week 64
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