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Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
EU CTIS ID: 2023-510200-42-00
What this study is testing
To show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) with regard to prevention of disease progression.
- 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.
- Verified PSC.
- Liver biopsy available.
- Women of child-bearing 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 drug. Hormonal methods other than levonorgestrel containing devices or medroxyprogesterone injections should be supplemented with use of a male condom. 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.
- Inclusion Criteria for the open-label extension (OLE) phase: 1. Signed additional informed consent for OLE phase
You likely can't join if
- History or presence of other concomitant liver diseases including.
- Well-founded doubt about the patient's cooperation.
- Existing or intended pregnancy or breast-feeding.
- Participation in another clinical trial within the last 30 days prior to screening visit.
- Patients who have an absolute contraindication for liver biopsy.
- 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).
See the full eligibility criteria
Who can join
- Signed informed consent.
- Males or females.
- Verified PSC.
- Liver biopsy available.
- Women of child-bearing 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 drug. Hormonal methods other than levonorgestrel containing devices or medroxyprogesterone injections should be supplemented with use of a male condom. 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.
- Inclusion Criteria for the open-label extension (OLE) phase: 1. Signed additional informed consent for OLE phase
- Inclusion Criteria for the open-label extension (OLE) phase: 2. DBE phase completed with Visit 22
What rules you out
- History or presence of other concomitant liver diseases including.
- Well-founded doubt about the patient's cooperation.
- Existing or intended pregnancy or breast-feeding.
- Participation in another clinical trial within the last 30 days prior to screening visit.
- Patients who have an absolute contraindication for liver biopsy.
- 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).
- Secondary causes of Sclerosing Cholangitis.
- Total bilirubin > 4.0 mg/dL (> 68 μmol/L) at screening or baseline.
- Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).
- Abnormal renal function.
- 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 on the interpretation of the results, or patient with atrial fibrillation 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Russian Federation
- 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, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Russian Federation; 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.