A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis



Status:Recruiting
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:7/28/2018
Start Date:November 29, 2017
End Date:December 2018
Contact:Brian J Byrnes
Email:bbyrnes@ljpc.com
Phone:858-256-7913

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A Phase 2, Multi-Center, Randomized, Placebo Controlled, Double-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

This study is a Phase 2 multicenter, randomized, placebo controlled, double-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.


Inclusion Criteria:

1. Patients with clinical diagnosis of hereditary hemochromatosis

2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary
hemochromatosis

3. Patients with elevated serum ferritin and TSAT levels

4. Female patients of child bearing potential must have a negative pregnancy test and
must be using a highly effective method of contraception during participation in the
study, and for 30 days after the last dose of study drug

5. Males must be surgically sterile (vasectomy), or using a highly effective method of
contraception during participation in the study, and for 30 days after the last dose
of study drug

6. Patient must be willing and able to provide written informed consent

Exclusion Criteria:

1. Patients receiving iron chelation therapy

2. Patients initiating phlebotomy treatments less than 6 months prior to the first dose
of study drug

3. Pregnant or lactating women

4. Patients taking an immunosuppressive agent

5. Patients participating in an unapproved investigational drug or investigational
therapeutic device within 30 days of study drug

6. Patients who are unwilling or unable to comply with the study protocol requirements

7. Patients with type 1 or poorly controlled type 2 diabetes

8. Patients must not have a medical condition that will interfere with the conduct of the
clinical study
We found this trial at
15
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