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COMPLETEDPHASE2

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

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

NCT03395704•La Jolla Pharmaceutical Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 serum ferritin and TSAT levels above treatment guidelines
•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 within 7 days prior to the first dose of study drug
•2. Patients initiating phlebotomy treatments less than 3 months prior to the first dose of study drug
•3. Pregnant or lactating women
•4. Patients taking an immunosuppressive agent without prior Sponsor approval
•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 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

Locations (31)

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

Key Dates

Start Date

November 29, 2017

Primary Completion Date

October 28, 2019

Completion Date

October 28, 2019

Last Updated

June 9, 2022

Enrollment

ACTUAL participants

Conditions

Hereditary Hemochromatosis

Interventions

LJPC-401

DRUG

Placebo

DRUG

PTG-300 in Subjects With Hereditary Hemochromatosis

NCT04202965

Hereditary Hemochromatosis

View study

UNKNOWNNA

Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

NCT05742035

Hereditary HemochromatosisHyperferritinemia

View study

COMPLETEDPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PTG-300 in Subjects With Hereditary Hemochromatosis

Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis