Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Protagonist Therapeutics, Inc.
This study is a multicenter, open-label study. The objective of the study is to assess the effect of PTG-300 on transferrin saturation (TSAT) and serum iron in adult hereditary hemochromatosis patients.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men and women aged 18 and older
Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype testing
Documented stable phlebotomy for ≥ 6 months
Screening hemoglobin \>11.5 g/dL
Documented evidence of prior serum ferritin ≥500 ng/mL
Serum ferritin \>50 ng/mL and \<300 ng/mL at screening
You may not be if
Clinically meaningful laboratory abnormality
Receiving iron chelation therapy
Receiving erythrocytapheresis
Pregnant or lactating females
Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infections requiring antimicrobial therapy within 4 weeks of dosing.
Serious or unstable medical or psychiatric condition that would prevent subject providing informed consent
Organ damage from iron overload
Primary or secondary immunodeficiency
Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection
Known history of autoimmune/inflammatory diseases
Any surgical procedures requiring general anesthesia within 1 month prior to screening or planned surgery during study
History of invasive malignancies within last 2 years, except non-malignant skin cancer and local cured prostate cancer, cervical cancer, or ductal carcinoma in situ
Receipt of an investigational agent within 30 days of screening
