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NCT06910943 · ClinicalTrials.gov registry record · Phase 2
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
A Phase 2 study of Liver Injury and Choline Deficiency, sponsored by Protara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 14
- Study locations
NCT06910943 is a Phase 2 study of Liver Injury and Choline Deficiency that is actively recruiting participants, run by Protara Therapeutics. The registered enrollment target is 129 participants. The trial reports 14 study locations across 5 states.
The verdict
NCT06910943, a Phase 2 study of Liver Injury and Choline Deficiency, is actively recruiting participants, sponsored by Protara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 14
- Study locations
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?
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, categorized as Phase 2. 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 7 total studies on file at ClinicalTrials.gov.
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.
NCT06910943 reports 14 study locations spanning 5 distinct geographic areas - top geographies include Other, Colorado, New York.
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.
What interventions are being tested in trial NCT06910943?
The interventions under investigation include: Placebo (DRUG), Choline Chloride for Injection (DRUG).
Who is sponsoring clinical trial NCT06910943?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
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