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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: Protara Therapeutics • ClinicalTrials.gov ID: NCT06910943

Registry updated: 2026-08-24
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Description

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.

Interventions

  • Choline Chloride for Injection (Drug)
    Intravenous use
  • Placebo (Drug)
    Intravenous use

Eligibility criteria

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 ≥10) at screening.

Conditions

Choline Deficiency Liver Injury

Locations

  • University of Colorado School of Medicine — Aurora, Colorado, United States
  • Floridian Clinical Research — Miami Lakes, Florida, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
  • Nebraska Medicine — Omaha, Nebraska, 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
  • Pinnacle Clinical Research- San Antonio — San Antonio, Texas, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record