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Trial record 31 of 277 for:    Non-alcoholic Steatohepatitis | United States

Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis (NASH-FX)

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ClinicalTrials.gov Identifier: NCT02421094
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Galectin Therapeutics Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: GR-MD-02 Drug: Placebo Phase 2

Detailed Description:

The primary objective is to determine the difference between placebo and GR-MD-02 treatment in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol.

Secondary objectives include evaluating differences between subjects treated with GR-MD-02 versus placebo in:

  • The baseline-adjusted change in liver stiffness as measured by MR-elastography
  • The baseline-adjusted change in liver stiffness as measured by FibroScan® scores.

An exploratory objective will be to evaluate the correlation of the three diagnostic modalities of LiverMultiScan, MR-Elastography, and FibroScan®.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Evaluate Non-Invasive Imaging Methods in Efficacy Assessment of GR-MD-02 for the Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : September 27, 2016


Arm Intervention/treatment
Active Comparator: GR-MD-02
Active
Drug: GR-MD-02
GM-MD-02 active
Other Name: galactoarabino-rhamnogalacturonate

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Mean change in liver fibrosis of corrected T1 (cT1) mapping (LiverMultiScan -LMS) [ Time Frame: 16 weeks ]
    difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS)


Secondary Outcome Measures :
  1. Baseline-adjusted change in liver stiffness with MR-elastography (MRE) [ Time Frame: 16 weeks ]
    Baseline-adjusted change in liver stiffness as measured by MR-elastography

  2. Baseline-adjusted change in liver stiffness by FibroScan® [ Time Frame: 16 weeks ]
    Baseline-adjusted change in liver stiffness as measured by FibroScan® scores



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421094


Locations
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United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Galectin Therapeutics Inc.

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Responsible Party: Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02421094     History of Changes
Other Study ID Numbers: GT-028
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases