This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Effect of LJPC-401 Versus Placebo on Blood Iron Levels
Percentage change in transferrin saturation (TSAT) as measured by blood laboratory tests.
Time frame: 16 Weeks
Effect of LJPC-401 Versus Placebo on Number of Phlebotomies
Time frame: 16 Weeks
Effect of LJPC-401 Versus Placebo on Blood Iron Levels
Change in serum ferritin as measured by blood laboratory tests
Time frame: 16 Weeks
Effect of LJPC-401 Versus Placebo on the Total Number of Treatment-emergent Adverse Events
Time frame: 20 Weeks
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Investigative Site
North Little Rock, Arkansas, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Palo Alto, California, United States
Investigative Site
Rialto, California, United States
Investigational Site
San Diego, California, United States
Investigative Site
San Francisco, California, United States
Investigative Site
Jacksonville, Florida, United States
Investigative Site
Indianapolis, Indiana, United States
Investigative Site
Wyoming, Michigan, United States
Investigative Site
Jackson, Mississippi, United States
...and 21 more locations