clinical trial · NCT03301506
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
Gilead Sciences·phase3·active not recruiting·n = 500
Primary Biliary CirrhosisSeladelpar 5 mg CapsuleSeladelpar 10 mg Capsule
brief summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
started
Dec 12, 2017
primary completion
Nov 1, 2028
completion
Nov 1, 2028
last updated
Dec 23, 2025
detailed description
Primary:
To evaluate the long-term safety and tolerability of seladelpar
Secondary:
* To evaluate the long-term efficacy of seladelpar * To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
official title
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol