Clinical trial: A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis (NCT03395704)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction