Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-Alcoholic Steatohepatitis (NASH)

In brief

The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.

Key facts

Study ID

NCT01899859

Run by

Galectin Therapeutics Inc.

People needed

31

Starts

2013-07-01

Expected to finish

2015-02-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects meeting all of the following criteria will be considered for admission to the study:
• Institutional Review Board (IRB approved written Informed Consent and privacy language as per national regulation (eg, Health Insurance Portability and Accountability Act [HIPAA] Authorization for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests.
• Subject is ≥ 18 years of age and < 75 years old at the time of consent.
• Subject has had a percutaneous liver biopsy within 12 months from Screening that shows a definitive diagnosis of NASH with advanced (Brunt stage 3) hepatic fibrosis.
• Sexually active males and females of childbearing potential must agree to use adequate contraception (condoms, intra-uterine contraceptive device, implants, injectables, sexual abstinence or vasectomized partner) throughout their participation in this study and for 30 days after the last dose of study drug. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to the first dose. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-child-bearing potential.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Subject is a pregnant or lactating female.
• 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. Significant alcohol consumption is defined as more than 20 gram per day in females and more than 30 grams per day in males, on average (a standard drink in the US is considered to be 14 grams of alcohol).
• Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment.
• Subject uses drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the year prior to Screening.
• Subject requires use of drugs with a narrow therapeutic window metabolized by CYP3A4 such as fast acting opioids (alfentanil and fentanyl), immunosuppressive drugs (cyclosporine, sirolimus, and tacrolimus), some cardiovascular agents (ergotamine, quinidine and dihydroergotamine), and select psychotropic agents (pimozide).
• Subject has prior or has planned (during the study period) bariatric surgery (eg, gastroplasty, Roux-en-Y gastric bypass).
• Subject has concurrent infection including diagnoses of fever of unknown origin and evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
• Subject with a platelet count below 100,000/mm3 at Screening.
• Subject with clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at Screening:
• Serum albumin less than 3.5 grams/deciliter (g/dL).
• An INR greater than 1.1.
• Direct bilirubin greater than 1.3 milligrams per deciliter (mg/dL).
• Subject has a history of bleeding esophageal varices, ascites or hepatic encephalopathy
• Subject has a history of hepatitis C. Patients found on screening to have hepatitis C antibody, even if PCR negative for HCV RNA, are excluded from this study.
• Subject has evidence of other forms of chronic liver disease:
• Hepatitis B as defined by presence of hepatitis B surface antigen.
• Evidence of ongoing autoimmune liver disease as defined by compatible liver histology.
• Primary biliary cirrhosis as defined by the presence of at least 2 of these criteria (i) Biochemical evidence of cholestasis based mainly on alkaline phosphatase elevation (ii) Presence of anti-mitochondrial antibody (iii) Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.
• Primary sclerosing cholangitis.
• Wilson's disease as defined by ceruloplasmin below the limits of normal and compatible liver histology.
• Alpha-1-antitrypsin deficiency as defined by diagnostic features in liver histology (confirmed by alpha-1 antitrypsin level less than normal; exclusion at the discretion of the study physician).
• History of hemochromatosis or iron overload as defined by presence of 3+ or 4+ stainable iron on liver biopsy.
• Drug-induced liver disease as defined on the basis of typical exposure and history.
• Known bile duct obstruction.

Where it is running

• Brooke Army Medical Ctr. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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