Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2020-03-19
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PTG-300
PTG-300 Subcutaneous
PTG-300
Active treatment with PTG-300 injected subcutaneously.
Interventions
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PTG-300
Active treatment with PTG-300 injected subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Protagonist Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Protagonist Investigational Site
Fayetteville, Georgia, United States
Protagonist Investigational Site
Bethesda, Maryland, United States
Protagonist Investigational Site
Charlotte, North Carolina, United States
Protagonist Investigational Site
Conroe, Texas, United States
Protagonist Investigational Site
Dallas, Texas, United States
Protagonist Investigational Site
Houston, Texas, United States
Protagonist Investigational Site
Houston, Texas, United States
Protagonist Investigational Site
Richmond, Virginia, United States
Protagonist Investigational Site
Seattle, Washington, United States
Protagonist Investigational Site
Halifax, Nova Scotia, Canada
Protagonist Investigational Site
Toronto, Ontario, Canada
Countries
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References
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Kowdley KV, Modi NB, Peltekian K, Vierling JM, Ferris C, Valone FH, Gupta S. Rusfertide for the treatment of iron overload in HFE-related haemochromatosis: an open-label, multicentre, proof-of-concept phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Dec;8(12):1118-1128. doi: 10.1016/S2468-1253(23)00250-9. Epub 2023 Oct 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PTG-300-06
Identifier Type: -
Identifier Source: org_study_id
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