Actively Recruiting
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Led by Protara Therapeutics · Updated on 2026-01-27
129
Participants Needed
14
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 12 years of age or older at time of informed consent
- Voluntarily provided written informed consent before entering the study
- Diagnosed with intestinal failure receiving long-term parenteral support when oral or enteral nutrition is not possible, insufficient, or contraindicated
- Receiving stable parenteral support at screening and throughout the study
- Receiving parenteral support at least 3 times per week for at least 6 months prior to screening
- Females of childbearing potential must have a negative urine pregnancy test at screening
You will not qualify if you...
- Taking steatogenic medications for 12 weeks or more within the past 12 months
- Using any medication that could affect liver fat measurement within 12 weeks prior to study start
- Having a systemic active infection at dosing time
- Planning to take non-study choline supplements or choline-containing multivitamins during the study
- Unwilling to limit alcohol intake to no more than 20g per day for 24 hours before screening and during the study
- Having active cancer (except basal cell skin tumor, low/very low risk prostate cancer, cervical carcinoma in situ, or locally resected cervical cancer)
- Having clinically significant kidney disease
- Having low vitamin B12 or serum folic acid levels below normal range
- Experiencing fulminant liver failure with active bleeding and/or brain dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
Not Yet Recruiting
3
Duke Clinic - Abdominal Transplant Research Office
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
University Hospitals Leuven, Campus Gasthuisberg
Leuven, Belgium, 3000
Not Yet Recruiting
6
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, Denmark, 9100
Not Yet Recruiting
7
Rigshospitalet - University Hospital Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
8
Beaujon Hospital - APHP
Clichy, France, 92110
Not Yet Recruiting
9
Rennes University Hospital Center - Pontchaillou Site
Rennes, France, 35000
Not Yet Recruiting
10
CHRU Nancy - Barbois Hospital
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
11
Charite - University Hospital Berlin
Berlin, Germany, 13353
Not Yet Recruiting
12
University Duisburg-Essen, University Hospital Essen
Essen, Germany, 45147
Not Yet Recruiting
13
M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center
Lodz, Poland, 90-532
Not Yet Recruiting
14
Czerniakowski Hospital Sp. z o.o. (LCC)
Warsaw, Poland, 00-739
Actively Recruiting
Research Team
C
Chief Scientific Operations Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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