Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis

Phase 3 Completed 53 enrolled Mirum Pharmaceuticals, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.

Timeline

Start: 2010-01
Primary completion: 2016-07
Completion: 2016-07

Publications

Heubi JE, Setchell KDR. Open-label Phase 3 Continuation Study of Cholic Acid in Patients With Inborn Errors of Bile Acid Synthesis. J Pediatr Gastroenterol Nutr. 2020 Apr;70(4):423-429. doi: 10.1097/MPG.0000000000002618.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholic Acid	Small molecule	10 mg/kg	Oral
Subject	Cholic Acid	Small molecule	15 mg/kg	Oral

Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis

Summary

Timeline

Publications

Drugs

Indications