RecruitingPhase 2Phase 3NCT06910943

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

A Phase 2b/3 Randomized Open-Label Dose-Selection Study With Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults With Intestinal Failure Receiving Long-Term Parenteral Support


Sponsor

Protara Therapeutics

Enrollment

129 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Choline Chloride for Injection and a drug called Placebo for people with choline deficiency and liver injury. The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCholine Chloride for Injection

Intravenous use

DRUGPlacebo

Intravenous use


Locations(17)

University of Colorado School of Medicine

Aurora, Colorado, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Nebraska Medicine

Omaha, Nebraska, United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, United States

Duke Clinic - Abdominal Transplant Research Office

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Pinnacle Clinical Research- San Antonio

San Antonio, Texas, United States

University Hospitals Leuven, Campus Gasthuisberg

Leuven, Belgium

Aalborg University Hospital, Department of Medical Gastroenterology

Aalborg, Denmark

Rigshospitalet - University Hospital Copenhagen

Copenhagen, Denmark

Beaujon Hospital - APHP

Clichy, France

Rennes University Hospital Center - Pontchaillou Site

Rennes, France

CHRU Nancy - Barbois Hospital

Vandœuvre-lès-Nancy, France

Charite - University Hospital Berlin

Berlin, Germany

University Duisburg-Essen, University Hospital Essen

Essen, Germany

M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center

Lodz, Poland

Czerniakowski Hospital Sp. z o.o. (LCC)

Warsaw, Poland

View Full Details on ClinicalTrials.gov

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NCT06910943


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