Back to resultsS-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Purpose
Primary Sclerosing Cholangitis (PSC)
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
S-Adenosyl-L-methionine (SAMe)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis (PSC) focused on measuring PSC
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.
Sites / Locations
- Department of Hepatology, Transplantology and Internal Medicine, Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S-adenosylmethionine (SAMe)
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in liver biochemistries
Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)
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).
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.
Change in Quality of Life
Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).
Change in pruritus severity
Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).
Change in liver stiffness
Change in liver stiffness on liver elastography (measured in kPa)
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT06026865
First Posted
June 9, 2023
Last Updated
September 4, 2023
Sponsor
Medical University of Warsaw
Collaborators
National Science Centre, Poland
1. Study Identification
Unique Protocol Identification Number
NCT06026865
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
National Science Centre, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis (PSC)
Keywords
PSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-adenosylmethionine (SAMe)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
S-Adenosyl-L-methionine (SAMe)
Other Intervention Name(s)
S-adenosylmethionine
Intervention Description
S-adenosyl-L-methionine 1200 mg/daily as 2400mg S-Adenosyl-L-methionine disulfate tosylate
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo of identical appearance, smell and taste, with the same schedule.
Primary Outcome Measure Information:
Title
Change in liver biochemistries
Description
Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)
Time Frame
6 months
Title
Change in Health-related Quality of Life
Description
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).
Time Frame
6 months
Title
Change in PSC-related Quality of Life
Description
Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire PBC-40.
Time Frame
6 months
Title
Change in Quality of Life
Description
Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).
Time Frame
6 months
Title
Change in pruritus severity
Description
Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).
Time Frame
6 months
Title
Change in liver stiffness
Description
Change in liver stiffness on liver elastography (measured in kPa)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Molecular assesment of hepatoprotective properties of SAMe
Description
Assessment of changes in antioxidant defence system (assessed as plasma MDA, SOD2, FGF-19, TNF-α, IL6, IL10, TGFβ, INFγ, homocysteine concentrations).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Bik, MD
Phone
+48 22 599 16 62
Email
emil.bik@uckwum.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Milkiewicz, MD, PhD
Organizational Affiliation
Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatology, Transplantology and Internal Medicine, Medical University of Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Bik, MD
Phone
+48 22 599 16 62
Email
emil.bik@uckwum.pl
12. IPD Sharing Statement
Plan to Share IPD
No
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S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
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