Overview

Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Abbott
Collaborator:
PPD
Criteria
Inclusion Criteria

- Subjects with non-alcoholic steatohepatitis based on histology in medical history
within the last 3 years

- Subjects in a stable metabolic condition since histology for NASH (Non-alcoholic
Steatohepatitis)

Exclusion Criteria

- Subjects with extrahepatic biliary obstruction

- Subjects with primary sclerosing cholangitis (PSC)

- Subjects with primary biliary cirrhosis (PBC)

- Any form of malignancy within the past 5 years and/or basal cell carcinoma and
squamous cell carcinoma of the skin within the past two years

- History of active substance abuse (oral, inhaled or injected) within one year prior to
the study

- Subjects with renal impairment (creatinine level of >2.0 mg/dL)

- Subjects with a known hypersensitivity to the active substance (ademetionine) or
methionine or to any of the inactive ingredients

- Subjects with known genetic defects affecting the methionine cycle and/or causing
homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase
deficiency, Vitamin B12 metabolism defect)

- Subjects on total parenteral nutrition in the year prior to screening

- Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight
loss surgery)

- Extrahepatic cholestasis (proven by ultrasound)

- Subjects with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >
5 upper limit of normal (ULN)

- Subject with serum total bilirubin (STB) > 5 ULN

- Subjects after liver transplantation and subjects on the waiting list for liver
transplantation

- Subjects with any of the following disease in medical history:

- Viral hepatitis (serum positive HBcAb (hepatitis B core antibody) or Hepatitis C Virus
(HCV) ribonucleic acid (RNA)

- Evidence of autoimmune liver disease

- Wilson's disease

- Hemochromatosis

- Alpha-1-antitrypsin deficiency

- Known positivity for antibody to human immunodeficiency virus (HIV)

- Known heart failure of New York heart Association class 3 or 4

- Current or history of significant alcohol consumption for a period of more than three
consecutive months within five years prior to screening (significant alcohol
consumption is defined as > 3 U (unit)/day for men and > 2 U/day for women, on
average) or binge drinking or inability to reliably quantify alcohol consumption.

- Clinical or histological evidence of cirrhosis F4

- Subjects with history of biliary diversion

- Subjects with uncontrolled diabetes mellitus defined by HbA1c (hemoglobin A1c) > 8.0 %
at screening

- Concomitant medication of B12, folate, betaine or choline

- Concomitant treatment with glitazone within the past year prior to the study

- Subjects with known folate or B12 deficiency

- BMI (body mass index) > 40 kg/m2

- History of major depression diagnostic and statistical manual of mental disorders
(DSM-IV) or bipolar disease

- Women of childbearing potential: positive urine pregnancy test during screening or
unwillingness to use an effective form of birth control during the study.

- Breastfeeding women

- Any condition that, in the opinion of the investigator, does not justify the patient's
inclusion into the study

- Investigational drug intake within one month prior to the study

- Active, serious medical disease with likely life-expectancy less than five years

- Uncooperative attitude or reasonable likelihood for non-compliance with the protocol
or any other reason that, in the investigator's opinion, prohibits the inclusion of
the subject into the study

- Legal incapacity or limited legal capacity, or who are incarcerated.

- Inability to return for scheduled visits.

- Inability to understand and follow the requirements of the protocol in the local
language