Status:
ACTIVE_NOT_RECRUITING
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
National Science Centre, Poland
Conditions:
Primary Sclerosing Cholangitis (PSC)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine i...
Detailed Description
The study is designed as a randomised, double-blind, placebo-controlled trial. Eighty participants will be randomized in 1:1 ratio to one of two arms of the study: Intervention or Placebo. Participan...
Eligibility Criteria
Inclusion
- primary sclerosing cholangitis fulfilling EASL criteria;
- age: 18 - 75 years;
- treatment with ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg b.w. for at least 6 months.
Exclusion
- inability to give informed consent;
- patients with other forms of chronic liver diseases;
- decompensated liver cirrhosis (Child-Pugh class B-C);
- patients with PSC who underwent stenting of their biliary tree within 6 months;
- other diseases or states that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure ≥ New York Heart Association (NYHA) II, organ transplantation, known HIV infection, rheumatoid arthritis, asthma, psychiatric disorders;
- treatment with: steroids, statins, rifampicin, antidepressants;
- pregnant or breastfeeding women;
- history of hypersensitivity reactions to S-adenosylmethionine;
- any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06026865
Start Date
August 1 2023
End Date
June 1 2026
Last Update
April 3 2025
Active Locations (1)
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1
Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
Warsaw, Poland