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

NCT02421094 | Completed Phase 2 Results

• 1 other identifier: GT-028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS)

  Difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS). LiverMultiScan is CE marked as a class IIa medical device. Corrected T1 (cT1) is a Magnetic Resonance (MR) relaxation parameter/measure from the device.The measure cT1 can be compared across different Magnetic Resonance Imaging (MRI) systems and sites. It is an emerging biomarker for rapid quantification of hepatic fibro-inflammatory disease. In unhealthy tissue, such as in inflamed and fibrotic tissues, measures result in longer cT1-relaxation.

  16 weeks

Secondary Outcomes (2)

• Baseline-adjusted Change in Liver Stiffness With MR-elastography (MRE)

  16 weeks

• Baseline-adjusted Change in Liver Stiffness by FibroScan®

  16 weeks

Study Arms (2)

GR-MD-02

ACTIVE COMPARATOR

Active

Drug: GR-MD-02

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GR-MD-02 DRUG

GM-MD-02 active

Also known as: galactoarabino-rhamnogalacturonate

GR-MD-02

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

belapectin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Vice President of Regulatory Affairs
• Organization: Galectin Therapeutics

horton@galectintherapeutics.com

678-620-3186

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 20, 2015
• Study Start: September 1, 2015
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: October 8, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-10

Locations

US (1)