PTG-300 in Subjects With Hereditary Hemochromatosis

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted at multiple sites and every patient will get treated with PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult hereditary hemochromatosis patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Protagonist Therapeutics; Protagonist Therapeutics, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 prostrate cancer, cervical cancer, or ductal carcinoma in situ

• Receipt of an investigational agent within 30 days of screening