At a glance
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A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis
In Brief
A Phase 2 clinical trial evaluating LJPC-401 and Placebo for Hereditary Hemochromatosis. Completed, enrolled 70 participants across 31 sites in 4 countries.
Detailed Summary
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 Details
Timeline
Interventions
LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg.
0.9% Sodium Chloride Injection, USP, or equivalent