Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
Status:
Terminated
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Primary objectives:
To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28,
following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic
liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of
liver inflammation.
To assess the safety and tolerability of GRI-0621 at these two doses.
Secondary objectives:
To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28,
following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic
liver disease and elevated serum levels of AST. Serum AST level will be used as a second
marker of liver inflammation.
To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in
serum ALT levels from baseline measured at the different trial time points.
To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following
daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver
disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or
apoptosis.
To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28
following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.
To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver
disease.
Exploratory objectives:
To assess the effect, if any, that the investigational product may have on serum triglyceride
levels.