CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7 enrolled
Drug / intervention
TAK-625drug
Likely dose
TAK-625 200 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05543174
NCT05543174Phase 3Completed
CompareCT.gov

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-625 in the Treatment of Subjects With Alagille Syndrome

Takeda·interventional·Posted Sep 16, 2022·Updated Jan 29, 2026

In Brief

A Phase 3 clinical trial evaluating TAK-625 for Alagille Syndrome (ALGS). Completed, enrolled 7 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlagille Syndrome (ALGS)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedSep 16, 2022
Enrollment StartJan 16, 2023
Primary CompletionOct 25, 2023
Study CompletionJul 25, 2025
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.8 years ago

Interventions

TAK-625drug

TAK-625 200 mcg or 400 mcg per kilogram, orally, once daily