Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Start Date
12/10/2025
Completion Date
6/1/2028
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 Criteria
Age Range: 12 years to No maximum
Interventions
Choline Chloride for Injection
Placebo
Conditions
Locations
University of Colorado School of Medicine
Aurora, Colorado 80045
United States
Floridian Clinical Research
Miami Lakes, Florida 33016
United States
Nebraska Medicine
Omaha, Nebraska 68105
United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York 10032
United States
Duke Clinic - Abdominal Transplant Research Office
Durham, North Carolina 27710
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Pinnacle Clinical Research- San Antonio
San Antonio, Texas 78229
United States
University Hospitals Leuven, Campus Gasthuisberg
Leuven, 3000
Belgium
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, 9100
Denmark
Rigshospitalet - University Hospital Copenhagen
Copenhagen, 2100
Denmark
Beaujon Hospital - APHP
Clichy, 92110
France
Rennes University Hospital Center - Pontchaillou Site
Rennes, 35000
France
CHRU Nancy - Barbois Hospital
Vandœuvre-lès-Nancy, 54511
France
Charite - University Hospital Berlin
Berlin, 13353
Germany
University Duisburg-Essen, University Hospital Essen
Essen, 45147
Germany
M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center
Lodz, 90-532
Poland
Czerniakowski Hospital Sp. z o.o. (LCC)
Warsaw, 00-739
Poland