Primary Sclerosing Cholangitis (PSC)NCT06026865
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
A study testing S-Adenosyl-L-methionine (SAMe) in people with Primary Sclerosing Cholangitis (PSC), run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- S-Adenosyl-L-methionine (SAMe)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
Warsaw
About this study
Official title: Clinical Effect and Molecular Mechanisms of Action of S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
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.
Read the 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)
- Being tested
- S-Adenosyl-L-methionine (SAMe), Placebo
- Keywords
- PSC
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Adenosyl-L-methionine (SAMe)Dietary supplement
Also called S-adenosylmethionine
S-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate
PlaceboOther
Placebo of identical appearance, smell and taste, with the same schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver biochemistries
Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)
Measured: 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).
Measured: 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.
Measured: 6 months
Change in Quality of Life
Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).
Measured: 6 months
Change in pruritus severity
Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).
Measured: 6 months
Change in liver stiffness
Change in liver stiffness on liver elastography (measured in kPa)
Measured: 6 months
Secondary outcomes (1)
Molecular assesment of hepatoprotective properties of SAMe
Assessment of changes in antioxidant defence system (assessed as plasma MDA, SOD2, FGF-19, TNF-α, IL6, IL10, TGFβ, INFγ, homocysteine concentrations).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023
- Primary completion28 Feb 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor
- Investigators
- Piotr Milkiewicz, MD, PhD, Principal investigator, Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026865
- Sponsor's protocol ID
- 2020/39/O/NZ5/03594
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Molecular Mechanisms of Action of S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT06026865
- Acronym / sponsor ID
- 2020/39/O/NZ5/03594
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Keywords
- PSC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-adenosylmethionine (SAMe) | Experimental | Dietary Supplement: S-Adenosyl-L-methionine (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. |
| Placebo | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-Adenosyl-L-methionine (SAMe)Also: S-adenosylmethionineS-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate | Dietary supplement | S-adenosylmethionine (SAMe) |
| PlaceboPlacebo of identical appearance, smell and taste, with the same schedule. | Other | Placebo |
Primary outcome
Change in liver biochemistries
Time frame: 6 months
Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)
Change in Health-related Quality of Life
Time frame: 6 months
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).
Change in PSC-related Quality of Life
Time frame: 6 months
Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire PBC-40.
Change in Quality of Life
Time frame: 6 months
Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).
Change in pruritus severity
Time frame: 6 months
Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).
Change in liver stiffness
Time frame: 6 months
Change in liver stiffness on liver elastography (measured in kPa)
1 secondary outcome
Molecular assesment of hepatoprotective properties of SAMe
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Milkiewicz, MD, PhD principal investigator
Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-Adenosyl-L-methionine (SAMe) in people with Primary Sclerosing Cholangitis (PSC), run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver biochemistries (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.