Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Choline Deficiency, Liver Injury
In brief
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.
Key facts
- Study ID
- NCT06910943
- Run by
- Protara Therapeutics
- People needed
- 129
- Starts
- 2025-12-10
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Czerniakowski Hospital Sp. z o.o. (LCC) — Warsaw, Poland (enrolling)
- Floridian Clinical Research — Miami Lakes, Florida, United States (enrolling)
- Rigshospitalet - University Hospital Copenhagen — Copenhagen, Denmark (enrolling)
- Beaujon Hospital - APHP — Clichy, France (enrolling)
- Charite - University Hospital Berlin — Berlin, Germany (enrolling)
- M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center — Lodz, Poland (enrolling)
- University of Colorado School of Medicine — Aurora, Colorado, United States (enrolling)
- Duke Clinic - Abdominal Transplant Research Office — Durham, North Carolina, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Pinnacle Clinical Research- San Antonio — San Antonio, Texas, United States (enrolling)
- University Hospitals Leuven, Campus Gasthuisberg — Leuven, Belgium (enrolling)
- Aalborg University Hospital, Department of Medical Gastroenterology — Aalborg, Denmark (enrolling)
- Nebraska Medicine — Omaha, Nebraska, United States
- Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York, United States
- University Duisburg-Essen, University Hospital Essen — Essen, Germany
- Rennes University Hospital Center - Pontchaillou Site — Rennes, France
- CHRU Nancy - Barbois Hospital — Vandœuvre-lès-Nancy, France
Full record on ClinicalTrials.gov
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