CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5 enrolled
Drug / intervention
TAK-625drug
Likely dose
Not stated in 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/NCT05543187
NCT05543187Phase 3Completed
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An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-625 in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis

Takeda·interventional·Posted Sep 16, 2022·Updated Jan 28, 2026

In Brief

A Phase 3 clinical trial evaluating TAK-625 for Progressive Familial Intrahepatic Cholestasis (PFIC). Completed, enrolled 5 participants across 8 sites.

Detailed Summary

The main aim of the study is to check if TAK-625 improves symptoms of Progressive Familial Intrahepatic Cholestasis (PFIC), 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 15 times from the start of study. After 15 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--
ConditionsProgressive Familial Intrahepatic Cholestasis (PFIC)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedSep 16, 2022
Enrollment StartJan 10, 2023
Primary CompletionSep 4, 2023
Study CompletionJul 22, 2025
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.8 years ago

Interventions

TAK-625drug

TAK-625 orally, twice daily (BID)