Choline chloride injections for adolescents and adults with intestinal failure on long-term parenteral support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2b/3 program that begins with an open-label dose-selection phase to evaluate safety, tolerability, and how the drug is distributed, followed by a randomized double-blind, placebo-controlled phase to test efficacy, each with an open-label extension of about a year. Adolescents (12 to <18) and adults (≥18) who have been on stable long-term parenteral support are eligible, and the dose-selection phase will pick two of three doses for the blinded comparison. Key outcomes include safety, liver-related measures, and correction of choline deficiency in patients receiving parenteral nutrition. The design combines initial open-label exposure to choose optimal doses with a subsequent placebo-controlled comparison to provide more rigorous efficacy data.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado School of Medicine
  Aurora, Colorado, United States Recruiting
• Floridian Clinical Research
  Miami Lakes, Florida, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Duke Clinic - Abdominal Transplant Research Office
  Durham, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Pinnacle Clinical Research- San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Chief Scientific Operations Officer
• Email: clinicaltrials@protaratx.com
• Phone: 16468440337

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.