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New treatment option for Choline Deficiency
Official title Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
ClinicalTrials.gov ID: NCT06910943
What this study is testing
What is Choline Chloride for Injection?
Choline Chloride for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for choline deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are...
- Females of childbearing potential must have a negative urine pregnancy test at screening Key
You likely can't join if
- Patients taking steatogenic medications for ≥ 12 weeks in the past 12 months; those taking any medicine that could affect the measurement of hepatic...
- 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...
- Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical...
- Clinically significant renal disease
See the full eligibility 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...
- Females of childbearing potential must have a negative urine pregnancy test at screening Key
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami Lakes, Florida, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- San Antonio, Texas, United States
- Leuven, Belgium
- Aalborg, Denmark
- Copenhagen, Denmark
- Clichy, France
- Rennes, France
- Vandœuvre-lès-Nancy, France
- Berlin, Germany
- Essen, Germany
- Lodz, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami Lakes, Florida, United States; Omaha, Nebraska, United States; New York, New York, United States; Durham, North Carolina, United States; Cleveland, Ohio, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.