A Phase 3 interventional study of norucholic acid in Primary Sclerosing Cholangitis, sponsored by Dr. Falk Pharma GmbH. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Treatment
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
This study's planned enrollment of 120 is above the median of 34 across 94 interventional studies indexed under Cholangitis, Sclerosing.
Browse Cholangitis, Sclerosing studies →Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
Drug: norucholic acid
500 mg norucholic acid film-coated tablets; 3 tablets/day
Occurrence of treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of serious treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of severe treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of adverse drug reactions
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of unexpected treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of treatment emergent adverse events leading to study withdrawal
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of adverse events leading to death
Time frame: 72 weeks from enrollment to end of treatment
No study locations are listed for this record.
Plan to share: No — It is not decided which data will be made available. A time frame cannot be indicated yet.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nor-ursodeoxycholic acid