NCT06260748

A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)

A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Chenodeoxycholic Acid (CDCA), With an Open-Label Cohort, in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Leadiant Biosciences, Inc. · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA.

Conditions

• Cerebrotendinous Xanthomatoses

Interventions

Type	Name	Description
DRUG	Chenodeoxycholic acid	250mg capsules
DRUG	Chenodeoxycholic acid Placebo	Placebo to match

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2024-02-15
• Last updated: 2024-11-18

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study