Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
NCT06910943 · View on ClinicalTrials.gov ↗
Study Summary
TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of Choline Chloride for Injection (Low Dose and High Dose) versus Placebo in adolescents (ages 12 to \< 18 years of age) and adults (≥ 18 years of age) with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated. Participants will be enrolled in one of 2 parts, each part will be followed by an open-label extension period of approximately a year. Part 1: Open-Label Dose-Selection Phase Part 2: Double-Blind, Placebo-Controlled Phase The purpose of the Open-Label Dose-Selection Phase is to evaluate the safety, tolerability, how Choline Chloride for Injection (study drug) is distributed in the body, and to select 2 of 3 doses for testing in the Double-Blind, Placebo-Controlled Phase. The purpose of the Double-Blind, Placebo-Controlled Phase is to assess the safety of the study drug and how well the study drug works at the 2 selected dose levels.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Choline Chloride for Injection
Study Locations (14)
Other
- University Hospitals Leuven, Campus Gasthuisberg — Leuven
- Aalborg University Hospital, Department of Medical Gastroenterology — Aalborg
- Rigshospitalet - University Hospital Copenhagen — Copenhagen
- Beaujon Hospital - APHP — Clichy
- Rennes University Hospital Center - Pontchaillou Site — Rennes
- CHRU Nancy - Barbois Hospital — Vandœuvre-lès-Nancy
- Charite - University Hospital Berlin — Berlin
- University Duisburg-Essen, University Hospital Essen — Essen
- M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center — Lodz
- Czerniakowski Hospital Sp. z o.o. (LCC) — Warsaw
Colorado
- University of Colorado School of Medicine — Aurora
New York
- Columbia University Medical Center/ New York Presbyterian Hospital — New York
North Carolina
- Duke Clinic - Abdominal Transplant Research Office — Durham
Ohio
- Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06910943
The ClinicalTrials.gov registry entry for NCT06910943 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protara Therapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Liver Injury appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06910943 reports 14 study locations spanning 5 distinct geographic areas — top geographies include Other, Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06910943 about?
NCT06910943 is a clinical study titled "Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support". TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of Choline Chloride for Injection (Low Dose and High Dose) versus Placebo in ado...
What is the current status of trial NCT06910943?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2025-12-10. Estimated completion is 2028-06.
What conditions does trial NCT06910943 study?
This clinical trial studies the following conditions: Liver Injury, Choline Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06910943?
The interventions under investigation include: Placebo (DRUG), Choline Chloride for Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06910943?
This trial is sponsored by Protara Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06910943 being conducted?
This trial has 14 study locations across Colorado, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.