AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2, Phase 3Ages 12 Years - anyAllProtara Therapeutics
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Male or female 12 years of age or older at the time of signing the informed consent * Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry * Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week * Females of childbearing potential must have a negative urine pregnancy test at screening Key Exclusion Criteria: * Participants taking steatogenic medications or any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to signing consent * Evidence of systemic active infection at the time of dosing * Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study * Participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study * Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer) * Clinically significant renal disease * Low B12 or low serum folic acid levels that are less than the normal range * Participants with severe hepatic impairment, defined as Child-Turcotte-Pugh (CTP) Class C (score โ‰ฅ10) at screening.
๐Ÿ’Š

What it tests

  • Choline Chloride for Injection
  • Placebo
๐Ÿ“

Where

18 sites
University of Colorado School of Medicine
Aurora, United States
Floridian Clinical Research
Miami Lakes, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
Nebraska Medicine
Omaha, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, United States
Duke Clinic - Abdominal Transplant Research Office
Durham, United States
Cleveland Clinic
Cleveland, United States
Pinnacle Clinical Research- San Antonio
San Antonio, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy