Status:
COMPLETED
A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis
Lead Sponsor:
La Jolla Pharmaceutical Company
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Hereditary Hemochromatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 hepci...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03395704
Start Date
November 29 2017
End Date
October 28 2019
Last Update
June 9 2022
Active Locations (31)
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1
Investigative Site
North Little Rock, Arkansas, United States, 72117
2
Investigative Site
Los Angeles, California, United States, 90036
3
Investigative Site
Palo Alto, California, United States, 94305
4
Investigative Site
Rialto, California, United States, 92377