SYFc918c1df575d4acdb67e8c577d68f392Registry ID: 2024-518652-23-00|UnknownResults
Cholic Acid trial
Long-term safety study of personalized cholic acid treatment in patients with bile acid synthesis defects
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Long-term safety study of personalized cholic acid treatment in patients with bile acid synthesis defects
interventional
N/A
1 country
1
To investigate the long-term safety of personalized cholic acid capsules treatment of patients with bile acid synthesis defects based on clinical and biochemical parameters.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2024
Actual (reported)Degree of suppression of endogenous bile acid synthesis (decrease in serum [and urine] DHCA and THCA bile acid intermediates)
Type and number of adverse events
Type and number of side effects
Increase in normal primary bile acids (increase in urine cholic acid [CA])
Change in serum ALT, AST, transaminases, γ-glutamyltrans- peptidase, conjugated bilirubin, total bilirubin levels, gamma-GT, alkaline phosphatase, alpha-1-phetoprotein
Change in liver protein synthesis (determined by albumin, pre-albumin and prothrombin time [PT])
Change in degree of coagulopathy (measured by PT, aPTT, Factor V and Factor VII)
Change in weight gain (weight-for-height percentile)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
CHOLIC ACID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
CHOLIC ACID
Named ingredient: Cholic acid
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amsterdam UMC Stichting
Amsterdam, 1105 AZ, Netherlands
Yasmin Polak
First Submitted
October 14, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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