Condition: Choline Deficiency · Liver Injury · Sponsor: Protara Therapeutics
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.
This description comes directly from the study's public registry record.
Chief Scientific Operations Officer · 16468440337 · clinicaltrials@protaratx.com
Always discuss trial participation with your own doctor first.
| University of Colorado School of Medicine | Aurora, Colorado, United States | Recruiting |
| Floridian Clinical Research | Miami Lakes, Florida, United States | Recruiting |
| Nebraska Medicine | Omaha, Nebraska, United States | Not Yet Recruiting |
| Columbia University Medical Center/ New York Presbyterian Hospital | New York, New York, United States | Not Yet Recruiting |
| Duke Clinic - Abdominal Transplant Research Office | Durham, North Carolina, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| Pinnacle Clinical Research- San Antonio | San Antonio, Texas, United States | Recruiting |
| University Hospitals Leuven, Campus Gasthuisberg | Leuven, Belgium | Recruiting |
| Aalborg University Hospital, Department of Medical Gastroenterology | Aalborg, Denmark | Recruiting |
| Rigshospitalet - University Hospital Copenhagen | Copenhagen, Denmark | Recruiting |
| Beaujon Hospital - APHP | Clichy, France | Recruiting |
| Rennes University Hospital Center - Pontchaillou Site | Rennes, France | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06910943