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

NCT06026865 | Active Not Recruiting

• 1 other identifier: 2020/39/O/NZ5/03594
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

PSC

Outcome Measures

Primary Outcomes (6)

• Change in liver biochemistries

  Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)

  6 months

• Change in Health-related Quality of Life

  Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire SF-36 (36-Item Short Form Survey).

  6 months

• Change in PSC-related Quality of Life

  Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire PBC-40.

  6 months

• Change in Quality of Life

  Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).

  6 months

• Change in pruritus severity

  Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).

  6 months

• Change in liver stiffness

  Change in liver stiffness on liver elastography (measured in kPa)

  6 months

Secondary Outcomes (1)

• Molecular assesment of hepatoprotective properties of SAMe

  6 months

Study Arms (2)

S-adenosylmethionine (SAMe)

EXPERIMENTAL

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.

Dietary Supplement: S-Adenosyl-L-methionine (SAMe)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

S-Adenosyl-L-methionine (SAMe) DIETARY_SUPPLEMENT

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

Also known as: S-adenosylmethionine

S-adenosylmethionine (SAMe)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

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

Warsaw, Poland

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Piotr Milkiewicz, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: September 7, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)