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Contact Information:

Dr Michael Stiess
+ 49 76115140
clinical.studies@drfalkpharma.de


Dr Palak Trivedi
+44 121 3718116
p.j.trivedi@bham.ac.uk


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Be Part of Research - Trial Details - An open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets
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An open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Birmingham London London Norwich

Medical Conditions

Primary sclerosing cholangitis (PSC)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


During the development of norucholic acid (NCA) over 700 patients have been treated with this new medication so far. This study, called NUT-022/PSC is a kind of follow-up study for the NUC-5/PSC study; it offers continuous NCA treatment to patients from the NUC-5/PSC study. Another goal of the current study is to gather more information about the safety and efficacy of NCA treatment for PSC patients over a longer time period. This is an open-label, single-arm study. Open-label means that the label of the study medication is not hidden, and that participants know which treatment they get. Single-arm means that all participants receive the same treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Mar 2025 31 Mar 2026

If patients are eligible, they will be asked if they would like to enrol in the NUT-022/PSC study. They will receive the medication NCA at a dose of 1500 mg per day, taken as three tablets (containing 500 mg NCA each), instead of the 6 capsules (250mg) in NUC-5/PSC study. This should make it easier and more comfortable for them to take the medication. Earlier studies showed that the capsules and the tablets both work in the body in the same way. The patient will come to regular interim visits every 3 months. The final visit will take place at the end of the treatment phase or at the time of participant’s withdrawal. Participants will have a total of 8 visits over a period of up to 72 weeks. Diagnostic procedures and examinations done in this study are mostly routine or non-invasive procedures. However, taking blood samples may cause discomfort or even clotting of the vein or nerve injury in rare cases. The total amount of blood withdrawn per visit is about 30 ml. Imaging (like ultrasound) is a non-invasive procedure. The trial will take place at 6 sites in UK which previously participated in the NUC-5/PSC study. Around 125 patients are expected to join globally and 20 expected in UK


To be able to take part, patients must have participated in the previous NUC-5/PSC study.

You can take part if:


Current inclusion criteria as of 23/05/2025:

Male and female patients ≥ 18 years, with PSC, who have participated in the NUC-5/PSC study.

You may not be able to take part if:


Current exclusion criteria as of 23/05/2025:

Patients who discontinued the NUC-5/PSC study due to adverse drug reactions (side effects of the study drug) are not eligible. Other exclusion criteria include chronic alcohol consumption, advanced cirrhosis, liver transplantation, severe infections and other severe diseases

_____

Previous exclusion criteria:

1. History or presence of chronic alcoholic consumption (daily consumption >30 g in men, >20 g in women)2. Abnormal renal function at screening 3. Thyroid-stimulating hormone (TSH) >ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if fT4 ismeasured and within the normal range).4. 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.5. Any active malignant disease6. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile7. Well-founded doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs.8. Existing or intended pregnancy or breast-feeding.9. 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 trial10. 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).11. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.12. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient’s safety.13. Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Royal Free London NHS Foundation Trust
    Royal Free Hospital Pond Street
    London
    NW3 2QG
  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB
  • Norfolk and Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY

Benefits:
There is no direct health benefit. The patient’s health condition may not improve or may even worsen while participating in this study.
The results of this study should help to develop and provide better treatment for patients with PSC in the future.
Another benefit is to further scientific knowledge; participation in this study will help scientists to gain further knowledge of the efficacy and safety of 1500 mg NCA per day when given over a longer period of time.
Risks:
The medication can trigger side-effects or allergic reactions, patients have been informed about this in the patient information and consent form and that the study doctor should be informed about the side effects for clinical management.
Diagnostic procedures (like the ultrasounds for abdomen and Liver stiffness) and examinations done in this clinical study are mostly routine or non-invasive procedures.
The Blood samples - might cause discomfort, bruising, or, unusually, clotting of the vein at the site where the needle is inserted or venous inflammation (thrombophlebitis) or nerve injury.

Dr Palak Trivedi
+44 121 3718116
p.j.trivedi@bham.ac.uk


Dr Michael Stiess
+ 49 76115140
clinical.studies@drfalkpharma.de



The study is sponsored by Dr Falk Pharma (Germany) and funded by Dr. Falk Pharma.



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Read full details for Trial ID: ISRCTN58756615
Last updated 23 May 2025

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