Phase 2b3 Study of Choline Chloride Injection in Adolescents and Adults With Intestinal Failure Receiving Long-Term Parenteral Support

What this Trial Is About

Researchers are evaluating Choline Chloride for Injection in adolescents aged 12 to under 18 years and adults aged 18 years and older who have intestinal failure and require long-term parenteral support because oral or enteral nutrition is not possible, insufficient, or contraindicated. This Phase 2b3 study aims to assess the safety and effectiveness of low and high doses of Choline Chloride compared to placebo. The study includes an open-label dose-selection phase, a double-blind placebo-controlled phase, and an open-label extension period. Participants will be enrolled into one of two parts an open-label dose-selection phase to evaluate safety, tolerability, and how the drug is processed in the body, and to select two doses for further testing followed by a double-blind, placebo-controlled phase to assess safety and efficacy of the selected doses. Each part is followed by an open-label extension lasting about one year, during which participants continue to receive treatment and monitoring. Throughout the study, participants will undergo regular assessments including plasma free choline measurements, liver function tests, MRI scans to evaluate liver fat and fibrosis, and quality of life questionnaires. Safety is closely monitored by tracking adverse events. The study lasts up to approximately 64 weeks, covering initial dosing phases and the extension period, to understand the long-term effects and safety of the treatment.

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