Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Intervention: GR-MD-02; Placebo
Intervention description: GM-MD-02 active; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial
      to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the
      Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced
      Fibrosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have liver biopsy demonstrating NASH with Brunt Stage 3 fibrosis within
             12 months of randomization. The subject is ≥ 18 years of age and ≤ 75 years old at the
             time of screening

          -  The subject is willing and able to provide written informed consent

          -  The subject is not pregnant and must have a negative pregnancy test prior to start of
             the study. Post-menopausal women must have been amenorrheic for at least 12 months to
             be considered of non-child-bearing potential.

          -  Fertile men and women participating in heterosexual relations must agree to use
             effective means of contraception throughout their participation in this study and for
             90 days after discontinuation of study medication.

          -  Lactating females must agree to discontinue nursing before the start of study
             treatment and refrain from nursing until 90 days after discontinuation of study
             medication.

          -  Male subjects must refrain from sperm donation throughout the study period and for a
             period of 90 days following the last dose of study drug.

        Exclusion Criteria:

          -  A history of hepatic decompensation including any episode of variceal bleeding,
             clinically detectable ascites, or overt hepatic encephalopathy.

          -  Status post TIPS (Transjugular Intrahepatic Porto-systemic Shunt) procedure.

          -  Evidence of other forms of chronic liver disease including viral hepatitis B or C,
             primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, alpha-1
             antitrypsin deficiency, alcoholic hepatitis, hemochromatosis, liver cancer, or history
             of biliary diversion.

          -  Any of the following laboratory values: Serum alanine aminotransferase (ALT) and
             aspartate aminotransferase levels > 10X upper limits of normal, Serum creatinine ≥ 2.0
             mg/dL, Platelet count < 60,000/mm3, Serum albumin ≤ 2.8 g/dL, INR ≥ 1.7, Direct
             bilirubin ≥ 2.0 mg/dL

          -  A MELD score ≥ 15 or Child-Pugh-Turcotte Stage B or C

          -  Known positivity for Human Immunodeficiency Virus (HIV) infection

          -  Any subject who had major surgery within 8 weeks of Day 1, significant traumatic
             injury, or anticipation of need for major surgical procedure during the course of the
             study.

          -  Weight reduction surgery within the past 3 years.

          -  Any subject with current, significant alcohol consumption or a history of significant
             alcohol consumption for a period of more than 3 consecutive months any time within 1
             year prior to screening will be excluded.

          -  Any subject with concurrent infection including diagnoses of fever of unknown origin
             (FUO) (subjects must be afebrile at the start of therapy).

          -  Any history of malignancy, except for the following adequately-treated non metastatic
             basal cell skin cancer; any other type of skin cancer, except melanoma, that has been
             adequately treated and has not recurred for at least 1 year prior to enrollment; and
             adequately treated in situ cervical cancer that has not recurred for at least 1 year
             prior to enrollment.

          -  Participation in an investigational new drug (IND) trial in the 30 days before
             randomization

          -  Clinically significant medical or psychiatric condition considered a high risk for
             participation in an investigational study.

          -  Failure to give informed consent

          -  Subjects with known allergies to the study drug or any of its excipients.

          -  Is an employee or family member of the investigator or study site personnel.

          -  Any subject who cannot undergo an MRI, e.g., due to certain metal or electronic device
             implants, as determined by the Principal Investigator.