drugset / Trial / NCT04524390
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
RandomizedParallel-groupTriple-blindTreatment
Summary
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
Timeline
- Start
- 2021-07-08
- Primary completion
- 2023-11-07
- Completion
- 2024-02-07
Outcome
Missed primary endpoint
registry p = 0.7419; Least-Square mean -0.39 (95% CI -2.76 to 1.97); MMRM NCT04524390 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maralixibat | Small molecule | — | — |