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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hereditary Hemochromatosis

In brief

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.

Key facts

Study ID

NCT03395704

Run by

La Jolla Pharmaceutical Company

People needed

70

Starts

2017-11-29

Expected to finish

2019-10-28

Last updated by the study team

2022-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with clinical diagnosis of hereditary hemochromatosis
• Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis
• Patients with serum ferritin and TSAT levels above treatment guidelines
• 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
• 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
• Patient must be willing and able to provide written informed consent

You may not qualify if…

• Patients receiving iron chelation therapy within 7 days prior to the first dose of study drug
• Patients initiating phlebotomy treatments less than 3 months prior to the first dose of study drug
• Pregnant or lactating women
• Patients taking an immunosuppressive agent without prior Sponsor approval
• Patients participating in an unapproved investigational drug or investigational therapeutic device within 30 days of study drug
• Patients who are unwilling or unable to comply with the study protocol requirements
• Patients with type 1 or poorly controlled type 2 diabetes
• Patients with a concomitant disease, disability or condition, including laboratory abnormality and ECG findings, which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, clinically significant arrhythmias, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease

Where it is running

• 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
• Investigative Site — East Setauket, New York, United States
• Investigative Site — Manhasset, New York, United States
• Investigative Site — New York, New York, United States
• Investigative Site — Dallas, Texas, United States
• Investigative Site — Fort Worth, Texas, United States
• Investigative Site — Houston, Texas, United States
• Investigative Site — San Antonio, Texas, United States
• Investigative Site — Seattle, Washington, United States
• Investigative Site — Liverpool, New South Wales, Australia
• Investigative Site — Westmead, New South Wales, Australia
• Investigative Site — Brisbane, Queensland, Australia
• Investigative Site — Herston, Queensland, Australia
• Investigative Site — Melbourne, Victoria, Australia
• Investigative Site — Murdoch, Western Australia, Australia
• Investigative Site — Bondy, France

Full record on ClinicalTrials.gov

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