drugset / Trial / NCT06197763

Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.

NCT06197763

Phase 1/2 Unknown 50 enrolled St. Boniface Hospital
RandomizedCrossoverTriple-blindTreatment

Summary

This is the first pilot study proposing a novel therapeutic option treating patients with Fontan circulation (FC), a high-risk condition that has no definite treatment options available, other than heart or heart-liver transplantation. The investigator's identification of elevated BA and their association with adverse clinical - investigational features in Fontan patients are novel.

Timeline

Start
2024-06-01
Primary completion
2025-11-01
Completion
2026-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 1875 mg