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Cholic acid

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

Ensayo de Mirum Pharmaceuticals, Inc. en errores innatos de la sintesis de acidos biliares.

Fase

Fase 3

Estado

Completado

Participantes

16

previstos

Centros

1

Fin del objetivo primario

ago 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2010.

Qué mide

Transaminasas sericas (At baseline and after 30 days of treatment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to compare the efficacy of these currently used capsules with the efficacy of the same treatment provided in a cholic acid capsule that is made by a company that will be marketed after FDA approval. At baseline, patients receive established doses of cholic acid capsules prepared at the Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients serve as their own controls, with baseline values presenting the reference value (CCHMC cholic acid capsule) and values after 30 days treatment presenting the value for the investigational treatment (TBM cholic acid capsule).

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Ficha completa en ClinicalTrials.gov (NCT01115582), actualizada en sep 2023.