S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

NCT ID: NCT06026865

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-06-01

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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

S-adenosylmethionine (SAMe)

Participants randomized to SAMe Group will receive S-adenosyl-L-methionine 1200 mg/daily (as 2400mg SAMe disulfate tosylate) in tablets in two divided doses (800mg in the morning and 400mg midday) over the period of 6 months. In addition, patients will receive standard treatment with ursodeoxycholic acid (UDCA) at a dose of 13-15 mg/kg b.w.

Group Type: EXPERIMENTAL

S-Adenosyl-L-methionine (SAMe)

Intervention Type: DIETARY_SUPPLEMENT

S-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate

Placebo

Patients in Placebo Group will receive a placebo of identical appearance, smell and taste, with the same schedule. In addition, patients will receive standard treatment with ursodeoxycholic acid (UDCA) at a dose of 13-15 mg/kg.In addition, patients will receive standard treatment with ursodeoxycholic acid (UDCA) at a dose of 13-15 mg/kg b.w.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo of identical appearance, smell and taste, with the same schedule.

Interventions

S-Adenosyl-L-methionine (SAMe)

S-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo of identical appearance, smell and taste, with the same schedule.

Intervention Type: OTHER

Other Intervention Names

S-adenosylmethionine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science Centre, Poland

OTHER_GOV

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Milkiewicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw

Locations

Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

2020/39/O/NZ5/03594

Identifier Type: -

Identifier Source: org_study_id