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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Protara Therapeutics
Study ID
NCT06910943
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Choline Deficiency
  • Liver Injury

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Choline Chloride for Injection — DRUG
    Intravenous use
  • Placebo — DRUG
    Intravenous use

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
129 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label, Dose-Selection: Dose 1
  • Experimental: Open-Label, Dose-Selection: Dose 2
  • Experimental: Open-Label, Dose-Selection: Dose 3
  • Experimental: Double-Blind, Placebo-Controlled: High Dose
  • Experimental: Double-Blind, Placebo-Controlled: Low Dose
  • Placebo Comparator: Double-Blind, Placebo-Controlled: Placebo
  • Experimental: Open Label Extension: High Dose
  • Experimental: Open Label Extension: Low Dose

Primary Outcome Measure

Open-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 Visits [ Time Frame: Week 1 to Week 8 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Colorado School of MedicineAuroraColorado80045
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Floridian Clinical ResearchMiami LakesFlorida33016
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Nebraska MedicineOmahaNebraska68105
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Columbia University Medical Center/ New York Presbyterian HospitalNew YorkNew York10032
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Duke Clinic - Abdominal Transplant Research OfficeDurhamNorth Carolina27710
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Cleveland ClinicClevelandOhio44195
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Pinnacle Clinical Research- San AntonioSan AntonioTexas78229
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Find similar trials in Aurora, CO

By research site
University of Colorado School of Medicine· Aurora, COFloridian Clinical Research· Miami Lakes, FLNebraska Medicine· Omaha, NEColumbia University Medical Center/ New York Presbyterian Hospital· New York, NYDuke Clinic - Abdominal Transplant Research Office· Durham, NCCleveland Clinic· Cleveland, OH

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