Status:
RECRUITING
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Lead Sponsor:
Protara Therapeutics
Conditions:
Choline Deficiency
Liver Injury
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- Patients taking steatogenic medications for ≥ 12 weeks in the past 12 months; those taking any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT06910943
Start Date
November 1 2025
End Date
June 1 2028
Last Update
November 24 2025
Active Locations (14)
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1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
2
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
3
Duke Clinic - Abdominal Transplant Research Office
Durham, North Carolina, United States, 27710
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195