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

Recruiting Phase 2 Phase 3 Interventional Study
Choline Deficiency Liver Injury
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
129 (estimated)
Sponsor
Protara Therapeutics · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 rece…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
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 w…
Contacts

Chief Scientific Operations Officer

16468440337

clinicaltrials@protaratx.com

CONTACT