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SAMe Trial for Patients With Alcoholic Cirrhosis

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ClinicalTrials.gov Identifier: NCT04250259
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Suthat Liangpunsakul, Indiana University

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date March 10, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
Measure the mortality of patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo [ Time Frame: Baseline to 24 months ]
The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAMe Trial for Patients With Alcoholic Cirrhosis
Official Title  ICMJE A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis
Brief Summary The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Alcoholic Cirrhosis
Intervention  ICMJE
  • Dietary Supplement: Placebo
    2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months
  • Dietary Supplement: SAMe 400 mg tablet
    SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Alcoholic Cirrhosis on placebo
    Intervention: Dietary Supplement: Placebo
  • Experimental: 1,200 mg SAMe
    SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
    Intervention: Dietary Supplement: SAMe 400 mg tablet
  • No Intervention: Non-drinking Controls
    Non-drinking healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2030
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria for patients with alcoholic cirrhosis

  1. Patients must have had alcohol consumption averaging at least 80 grams per day (for men) or 50 grams per day (for women), for at least 10 years. These criteria are based on epidemiological evidence of the alcohol-cirrhosis relationship. The cutoff was set at a relatively high level so as to minimize the chance that cirrhosis was caused by factors other than alcohol
  2. Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
  3. subjects with clinical presentation either in Child Class A or B at the time of enrollment

Inclusion criteria for healthy control :

  1. individuals 18 to 70 years old
  2. able to provide informed consent
  3. subjects do not consume any alcohol or those who drink < 50 grams per day on average in women and < 80 grams per day on average in men and do not consume any alcohol within 3 months before the study and
  4. subjects are healthy without underlying acute or chronic medical conditions.

Exclusion criteria for patients with alcoholic cirrhosis

  1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
  2. Serum creatinine >1.5 mg/dl
  3. Known co-existing infection with hepatitis C, hepatitis B, or HIV
  4. Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
  5. Gastrointestinal bleeding within the prior 28 days3
  6. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
  7. Women who are pregnant, may become pregnant, or nursing
  8. Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
  9. Subjects with history of/diagnosis of hepatocellular carcinoma
  10. Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
  11. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
  12. Systemic antibiotic use or use of rifaximin for 10 days or more in last 2 months before the enrollment.

Exclusion criteria for all healthy control participants:

  1. individuals under the age of 18 or over the age of 70
  2. not able to provide informed consent
  3. subjects who consume any alcohol or those who drink > 50 grams per day on average in women and > 80 grams per day on average in men and consume any alcohol within 3 months before the study and
  4. subjects that are unhealthy with underlying acute or chronic medical conditions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kristina Chandler, BS (317) 988-4733 krimhick@iu.edu
Contact: AdePeju Oshodi, BS (317) 988-4545 afoshodi@iu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250259
Other Study ID Numbers  ICMJE SAMe Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suthat Liangpunsakul, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suthat Liangpunsakul, MD Indiana University
PRS Account Indiana University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP