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An Open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets
EU CTIS ID: 2024-514292-18-00
What this study is testing
To evaluate safety and tolerability of norucholic acid (NCA) film-coated tablets in the treatment of Primary Sclerosing Cholangitis (PSC).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent.
- Males or females ≥ 18 years.
- Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and • has completed the DBE phase with Visit 22, or • has prematurely terminated the DBE phase before this trial has been started, or • has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy* *Lack of efficacy as defined in the NUC-5/PSC trial
- Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence (only accepted as a highly effective contraceptive measure if it is the usual and preferred lifestyle of the patient), throughout the treatment period and for four weeks following the last dose of study treatment. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the patient has this adequate birth control for study participation.
You likely can't join if
- History or presence of chronic alcoholic consumption (daily consumption > 30 g in men, > 20 g in women).
- Abnormal renal function at screening
- Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if fT4 is measured and within the normal range).
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance, or any disorder which in the opinion of the investigator may affect the patient’s safety.
- Any active malignant disease.
- Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
See the full eligibility criteria
Who can join
- Signed informed consent.
- Males or females ≥ 18 years.
- Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and • has completed the DBE phase with Visit 22, or • has prematurely terminated the DBE phase before this trial has been started, or • has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy* *Lack of efficacy as defined in the NUC-5/PSC trial
- Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence (only accepted as a highly effective contraceptive measure if it is the usual and preferred lifestyle of the patient), throughout the treatment period and for four weeks following the last dose of study treatment. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the patient has this adequate birth control for study participation.
What rules you out
- History or presence of chronic alcoholic consumption (daily consumption > 30 g in men, > 20 g in women).
- Abnormal renal function at screening
- Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if fT4 is measured and within the normal range).
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance, or any disorder which in the opinion of the investigator may affect the patient’s safety.
- Any active malignant disease.
- Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
- Well-founded doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs.
- Existing or intended pregnancy or breast-feeding.
- Participation in another clinical trial (other than the NUC-5/PSC trial) within the last 30 days prior to screening visit, simultaneous participation in another clinical trial, or previous enrolment in this trial and intake of Investigational Medicinal Product (IMP) within this trial
- Imprisoned persons, persons admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent (e.g. due to mental impairment).
- Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
- Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient’s safety.
- Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.