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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05543187
Study type Interventional
Source Takeda
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 10, 2023
Completion date May 9, 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT03353454 - A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) Phase 3
Completed NCT02057718 - Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis Phase 2
Completed NCT03905330 - A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC) Phase 3
Active, not recruiting NCT04185363 - An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC) Phase 3