Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03602560
Brief Summary:
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Detailed Description:
Primary:
* To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo
Key Secondary:
* To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP) levels
* To evaluate the effect of seladelpar on pruritus
Study:
NCT03602560
Study Brief:
Protocol Section:
NCT03602560