Study on Norucholic Acid for Treating Primary Sclerosing Cholangitis in Patients

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What is this study about?

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The trial is testing a treatment using a medication called norursodeoxycholic acid, also known as norucholic acid or NUC01. This medication is a synthetic form of a bile acid and is taken in the form of hard capsules. The study will compare the effects of NUC01 with a placebo to see if it can help prevent the progression of PSC.

The purpose of the study is to determine if NUC01 is more effective than a placebo in treating PSC. Participants in the study will be randomly assigned to receive either the NUC01 capsules or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for a period of time, during which participants will take the medication and have regular check-ups to monitor their health and the progression of the disease.

Throughout the study, the main goal is to observe whether there is a partial normalization of a liver enzyme called s-ALP and to ensure there is no worsening of the disease stage. Secondary observations will include liver stiffness, fibrosis stage, liver histology, and quality of life. The study aims to provide valuable information on the effectiveness of NUC01 in managing PSC and potentially improving the lives of those affected by this condition.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding and agreement to participate in the clinical trial.

You will be asked to confirm your eligibility, which includes being diagnosed with primary sclerosing cholangitis (PSC) and having a liver biopsy available.

2 randomization and treatment assignment

You will be randomly assigned to receive either the study medication, norursodeoxycholic acid (norUDCA), or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

The medication will be provided in the form of hard capsules for oral use.

3 medication administration

You will take the assigned medication as directed by the study team. The dosage, frequency, and duration of administration will be specified by the study protocol.

It is important to follow the instructions carefully and report any side effects or concerns to the study team.

4 regular study visits

You will attend regular study visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and other assessments as required by the study protocol.

The study team will evaluate your progress and adjust the treatment plan if necessary.

5 completion of the double-blind phase

After completing the double-blind phase of the study, you will have a final visit to assess your condition and the outcomes of the treatment.

If eligible, you may be invited to participate in an open-label extension (OLE) phase, where you will receive additional information and provide consent for continued participation.

6 open-label extension phase

If you choose to participate in the open-label extension phase, you will continue to receive the study medication, and your health will be monitored as before.

This phase allows for further evaluation of the treatment’s long-term effects and benefits.

Who Can Join the Study?

Signed informed consent: You must agree to participate in the study by signing a document that explains the study and your role in it.
Gender: Both males and females can participate.
Verified Primary Sclerosing Cholangitis (PSC): You must have a confirmed diagnosis of PSC.
Liver biopsy available: A sample of your liver tissue must be available for examination.
Women of child-bearing potential: If you are a woman who can become pregnant, you must use a highly effective method of birth control during the study and for four weeks after the last dose of the study drug. This includes methods like hormonal contraception, an intrauterine device (IUD), or having a partner who has had a vasectomy. If you are not able to have children (surgically sterile or post-menopausal for at least 2 years), this does not apply.
Inclusion for the open-label extension (OLE) phase: You must sign an additional consent form for this phase and have completed the previous phase of the study.

Who Cannot Join the Study?

Patients who have a different liver disease other than Primary Sclerosing Cholangitis (PSC).
Patients who have had a liver transplant.
Patients who are currently taking medications that could interfere with the study treatment.
Patients who have a history of alcohol or drug abuse.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that could affect their participation in the study.
Patients who have participated in another clinical trial within the last 30 days.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Medizinische Hochschule Hannover	Hanover	Germany
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Medical University Of Graz	Graz	Austria
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
ID Clinic	Myslowice	Poland
University Of Debrecen	Debrecen	Hungary
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hopital Beaujon	Clichy	France
Uaijfeylxa Mcomutd Cvovia Hipqqcadhnmofxzez	Hamburg	Germany
iepxakthxku Gkyj	Hamburg	Germany
Altyjeljr Uvb	Amsterdam	The Netherlands
Analmmbi Utpyyttsvm Hrkimakd	Lorenskog	Norway
Haqmk Bteumt Hr	Bergen	Norway
Htftkdjw Ucjafrbrok Cnhssfb Hmvqktzi	Helsinki	Finland
Axidoi Ujxxepuoto Hlxjldfc	Aarhus	Denmark
Geigsr Uohpuegzlp Fyjaifixq	Frankfurt	Germany
Kjvonnxi dui Undhgwqqzuzi Mzyellzf Ard	Munich	Germany
Uurgeurbuobrhujmfjuqm Witzmsbhj Akv	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	09.01.2018
Denmark	Not recruiting	09.01.2018
Finland	Not recruiting	09.01.2018
France	Not recruiting	09.01.2018
Germany	Not recruiting	09.01.2018
Hungary	Not recruiting	09.01.2018
Norway	Not recruiting	09.01.2018
Poland	Not recruiting	09.01.2018
The Netherlands	Not recruiting	09.01.2018

Trial locations

Investigated drugs:

Norucholic Acid

Norursodeoxycholic Acid (norUDCA) is a medication being studied for its potential to help people with a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts, which carry bile from the liver to the small intestine, become inflamed and scarred. This can lead to liver damage over time. Norursodeoxycholic Acid is being tested to see if it can slow down or prevent the progression of this disease, helping to maintain liver function and improve the quality of life for patients.

Primary Sclerosing Cholangitis (PSC) – Primary Sclerosing Cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the scarring can cause the bile ducts to become blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually lead to liver cirrhosis. The disease often progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itching, and jaundice, which is a yellowing of the skin and eyes. The exact cause of PSC is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis.

Trial ID:

2023-510200-42-00

Protocol code:

NUC-5/PSC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Norucholic Acid for Treating Primary Sclerosing Cholangitis in Patients

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