Clinical trial NCT06026865: S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Official title: Clinical Effect and Molecular Mechanisms of Action of S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Sclerosing Cholangitis (PSC)
Keywords: PSC
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2023-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.

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. Participants in Intervention Group will be treated with S-adenosyl-L-methionine 1200 mg/daily in tablets in two divided doses (800mg in the morning and 400mg midday) over the period of 6 months. Patients in Placebo Group will receive a placebo of identical appearance, smell and taste, with the same schedule.

Participants will be monitored in out-patient clinic at baseline, interim visits at weeks: 4, 12, end of treatment at 24 weeks and follow-up visit after 4-6 weeks wash-out period. Treatment adherence, adverse events, serum biochemistry and health related quality of life will be assessed at each visit. Liver fibrosis will be measured with transient elastography at baseline and at the end of treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in liver biochemistries
timeFrame: 6 months
measure: Change in Health-related Quality of Life
timeFrame: 6 months
measure: Change in PSC-related Quality of Life
timeFrame: 6 months
measure: Change in Quality of Life
timeFrame: 6 months
measure: Change in pruritus severity
timeFrame: 6 months
measure: Change in liver stiffness
timeFrame: 6 months
Secondary outcomes:
measure: Molecular assesment of hepatoprotective properties of SAMe
timeFrame: 6 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
Study officials:
affiliation: Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
name: Piotr Milkiewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: