drugset / Trial / NCT05543174

A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)

NCT05543174

Phase 3 Completed 7 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The main aim of the study is to check if TAK-625 improves symptoms of Alagille Syndrome (ALGS), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time. This will help the study sponsor (Takeda) to work out the best dose to give people in the future. The participants will be treated with TAK-625 for up to the end of study (about 34 months). Participants will visit their study clinic 9 times from the start of study. After 9 times visits, participants will visit their study clinic every 12 weeks up to the end of study.

Timeline

Start
2023-01-16
Primary completion
2023-10-25
Completion
2025-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Maralixibat Small molecule 400 ug/kg Oral

Indications