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A Phase 2b/3 Randomized Open-Label Dose-Selection Study With Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults With Intestinal Failure Receiving Long-Term Parenteral Support

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Trial Profile

A Phase 2b/3 Randomized Open-Label Dose-Selection Study With Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults With Intestinal Failure Receiving Long-Term Parenteral Support

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Choline chloride (Primary)
  • Indications Liver disorders
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms THRIVE-3

Most Recent Events

  • 08 May 2025 According to a Protara Therapeutics media release, company plans to initiate (dosing of first patient) THRIVE-3 clinical trial, in the third quarter of 2025.
  • 09 Sep 2024 According to a Protara Therapeutics media release, company expects to dose first patient in pivotal PK trial for IV Choline Chloride in Q1 2025
  • 09 Apr 2024 New trial record

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