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Study on the Safety and Tolerability of Norucholic Acid Tablets for Patients with Primary Sclerosing Cholangitis (PSC)

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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 study will use a treatment called norucholic acid, which is provided in the form of film-coated tablets. Norucholic acid is a synthetic version of a naturally occurring substance in the body known as bile acid.

The purpose of this study is to evaluate the safety and tolerability of norucholic acid in patients with PSC. Participants in the study will take norucholic acid tablets orally. The study will monitor participants over a period to observe any side effects or reactions to the treatment. The study will also look at changes in liver health and other safety measures, such as blood pressure and body weight.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur during the treatment. The study aims to ensure that norucholic acid is safe for use in treating PSC and to understand how it affects the liver and overall health of the participants. The study is open-label, meaning both the researchers and participants know what treatment is being administered.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of primary sclerosing cholangitis (PSC) and ensuring previous participation in the NUC 5/PSC trial.

Eligibility criteria include being 18 years or older and having signed informed consent. Women of childbearing potential must use effective birth control during the study and for four weeks after the last dose.

2 medication administration

The study involves taking norucholic acid tablets, known as NUT01. These are film-coated tablets taken orally.

The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.

3 monitoring and follow-up

Regular monitoring is conducted to evaluate the safety and tolerability of the treatment. This includes checking for any treatment-emergent adverse events (TEAEs), serious TEAEs, severe TEAEs, adverse drug reactions (ADRs), and unexpected TEAEs.

Secondary assessments involve monitoring changes in vital signs, body weight, hematology, serum chemistry, urinalysis, liver stiffness, and s-ALP levels from baseline to the end of treatment.

4 completion of study

The study is estimated to end on September 30, 2027. Participants will continue to be monitored until the end of the study period.

Upon completion, a final assessment is conducted to evaluate the overall safety and efficacy of the treatment.

Who Can Join the Study?

  • The patient must provide a signed informed consent, which means they agree to participate in the study after being informed about it.
  • The patient must be a male or female who is 18 years or older.
  • The patient must have been previously diagnosed with Primary Sclerosing Cholangitis (PSC), a liver disease.
  • The patient must have participated in a previous trial called NUC 5/PSC and either:
    • Completed the DBE phase with Visit 22, or
    • Left the DBE phase early before this new trial started, or
    • Left the DBE phase early after this new trial started, but only if it was due to the treatment not working well enough.
  • Women who can have children must use a highly effective birth control method with a very low chance of failure (less than 1% per year) during the study and for four weeks after the last dose. This includes methods like:
    • Hormonal birth control that stops ovulation (oral, vaginal, or skin patch)
    • Progestogen-only hormonal birth control (oral, injection, or implant)
    • Intrauterine device (IUD) or hormone-releasing system (IUS)
    • Surgical methods like bilateral tubal occlusion or having a partner who has had a vasectomy
    • Choosing not to have sex, if this is the usual lifestyle choice
  • Women who cannot have children can participate if they are surgically sterile or have not had a menstrual period for at least two years, which is known as being post-menopausal.

Who Cannot Join the Study?

  • Patients who have a different liver condition other than Primary Sclerosing Cholangitis (PSC) cannot participate. PSC is a disease that affects the bile ducts in the liver.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to take the study medication, which is a film-coated tablet, cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who are participating in another clinical trial at the same time cannot join this study.
  • Patients who have a history of allergic reactions to similar medications cannot participate.
  • Patients who have a history of substance abuse or alcohol abuse cannot participate.
  • Patients who have a serious mental health condition that might interfere with their ability to participate cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
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
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
ID Clinic Myslowice Poland
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Hopital Beaujon Clichy France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Upqlksxvwh Mjyqdaw Celzpc Hgbckkwjehwrkkrmg Hamburg Germany
Uwzucewzctzhfwflxurqg Erali Acv Essen Germany
Arixdmmpi Ujj Amsterdam The Netherlands
Amkvttwq Uhjsqprykz Hovioiye Lorenskog Norway
Atszqr Ujosuecvka Hkvkmnbx Aarhus Denmark
Glsejt Upnxxhqfkq Fxesdiobr Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
31.01.2025
Belgium Belgium
Not recruiting
31.01.2025
Denmark Denmark
Not recruiting
31.01.2025
France France
Not recruiting
31.01.2025
Germany Germany
Not recruiting
31.01.2025
Hungary Hungary
Not recruiting
31.01.2025
Norway Norway
Not recruiting
31.01.2025
Poland Poland
Not recruiting
31.01.2025
Sweden Sweden
Not recruiting
31.01.2025
The Netherlands The Netherlands
Not recruiting
31.01.2025

Trial locations

Investigated drugs:

Norucholic Acid is being studied for its safety and how well it is tolerated in patients with Primary Sclerosing Cholangitis (PSC). This medication is provided in the form of film-coated tablets and is intended to help manage the symptoms of PSC, a disease that affects the bile ducts in the liver.

Primary Sclerosing Cholangitis – This 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 failure. The disease 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 Primary Sclerosing Cholangitis is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis.

Trial ID:
2024-514292-18-00
Protocol code:
NUT-022/PSC
Trial Phase:
Therapeutic confirmatory (Phase III)

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