Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
NCT ID: NCT06910943
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
129 participants
INTERVENTIONAL
2025-12-10
2028-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Open-Label, Dose-Selection: Dose 1
Choline Chloride for Injection
Intravenous use
Open-Label, Dose-Selection: Dose 2
Choline Chloride for Injection
Intravenous use
Open-Label, Dose-Selection: Dose 3
Choline Chloride for Injection
Intravenous use
Double-Blind, Placebo-Controlled: High Dose
Choline Chloride for Injection
Intravenous use
Double-Blind, Placebo-Controlled: Low Dose
Choline Chloride for Injection
Intravenous use
Double-Blind, Placebo-Controlled: Placebo
Placebo
Intravenous use
Open Label Extension: High Dose
Choline Chloride for Injection
Intravenous use
Open Label Extension: Low Dose
Choline Chloride for Injection
Intravenous use
Interventions
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Choline Chloride for Injection
Intravenous use
Placebo
Intravenous use
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Fulminant liver failure, with active bleeding and/or encephalopathy
12 Years
ALL
No
Sponsors
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Protara Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Scientific Operations Officer
Role: STUDY_DIRECTOR
Protara Therapeutics
Locations
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University of Colorado School of Medicine
Aurora, Colorado, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States
Duke Clinic - Abdominal Transplant Research Office
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals Leuven, Campus Gasthuisberg
Leuven, , Belgium
Aalborg University Hospital, Department of Medical Gastroenterology
Aalborg, , Denmark
Rigshospitalet - University Hospital Copenhagen
Copenhagen, , Denmark
Beaujon Hospital - APHP
Clichy, , France
Rennes University Hospital Center - Pontchaillou Site
Rennes, , France
CHRU Nancy - Barbois Hospital
Vandœuvre-lès-Nancy, , France
Charite - University Hospital Berlin
Berlin, , Germany
University Duisburg-Essen, University Hospital Essen
Essen, , Germany
M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center
Lodz, , Poland
Czerniakowski Hospital Sp. z o.o. (LCC)
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Use Central Contact
Role: primary
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Other Identifiers
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TARA-001-301
Identifier Type: -
Identifier Source: org_study_id
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