NCT01115582Phase 3Completed

Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

Study sponsor: Mirum Pharmaceuticals, Inc. · MIRM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2010-08Actual

Enrollment · participants16Actual

Source updated2023-10-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Inborn Errors of Bile Acid Synthesis

Treatments or interventions studied

Cholic acidDrug

Primary outcomes · main study measures

Read the study measures

measure: Serum Transaminases; description: Concentration of serum alanine transaminase (ALT) and aspartate transaminase (AST); timeFrame: At baseline and after 30 days of treatment; measure: Serum and Urine Bile Acids; description: Concentration of bile acids in serum (S) and urine (U). (abbreviations: chol.=cholenoic; monohydro=monohydroxy; dihydro=monohydro); timeFrame: At baseline (BL) and after 30 days of treatment (D30)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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