A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera - PTG-300-11

Protagonist Therapeutics, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Protagonist Therapeutics, Inc.
入组人数: 10

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Inclusion Criteria: Subjects must meet ALL of the following inclusion criteria:
•1. Male and female subjects aged 18 (or the minimum country specific age of
•consent if >18) years or older.
•2. Subject understands the study procedures, is willing and able to adhere to
•study requirements and agrees to participate in the study by giving written
•informed consent.
•3. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis
•of polycythemia vera.
•4. Phlebotomy requiring defined as ALL of the following:
•a. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks
•before randomization or at least 5 phlebotomies due to inadequate hematocrit
•control in 1 year before randomization, and
•b. Last phlebotomy due to inadequate hematocrit control within 3 months before
•randomization, and
•c. No phlebotomy within 6 days prior to randomization.
•Note: Phlebotomies performed within an 8-day period will be counted as a single
•phlebotomy.
•5. CBC values immediately prior to randomization:
•a. Hematocrit <45%,
•b. WBC 4000/µL to 20,000/µL (inclusive) and
•c. Platelets 100,000/µL to 1,000,000/µL (inclusive).
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
•7. Women of childbearing potential (WOCBP) agree to use medically acceptable
•contraception (<1% annual failure rate) during the study and for 30 days after
•the last dose of study drug.
•8. A female subject must agree not to donate eggs (ova, oocytes) for the
•purposes of assisted reproduction during the study and for a period of 30 days
•after receiving the last dose of study medication.
•9. Men with partners of childbearing potential agree to use medically
•acceptable contraception (<1% annual failure rate) during the study and for 90
•days after the last dose of study drug. In addition, men must use a condom
•during the study and for 90 days after the last dose of study drug regardless
•of the partner*s childbearing potential.
•10. A male subject must agree not to donate sperm for the purpose of
•reproduction during the study and for a minimum of 90 days after receiving the
•11. Subjects receiving cytoreductive therapy at randomization must be on a
•stable PV therapy regimen as follows:
•a. Hydroxyurea - at least 2 months
•b. JAK inhibitor - at least 2 months
•c. Interferon - at least 6 months
•Note: A *stable dose regimen* of cytoreductive therapy does not mean an
•unchanged dose regimen. Temporary adjustments in dose regimen or temporary
•suspension of dosing are allowed. However, the total weekly dose of hydroxyurea
•and JAK inhibitor or total monthly dose of interferon may not be higher at
•randomization than the dose at the beginning of the pre-randomization
•observation period. The pre-randomization observation period is
•2 months for hydroxyurea and JAK inhibitor and 6 months for interferon
•12. Subjects treated with phlebotomy alone at randomization must have stopped:
•a. Hydroxyurea at least 2 months before screening
•b. JAK inhibitor at least 2 months before screening
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排除标准

•Exclusion Criteria: Subjects must not meet ANY of the following exclusion
•criteria to be enrolled:
•1. Clinically meaningful laboratory abnormalities at Screening including, but
•not limited to:
•a. Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
•b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2.5 ×
•upper limit of normal (ULN)
•c. Total bilirubin >1.5 × ULN.
•Note: Screening laboratory tests with abnormal results (if considered by the
•investigator to be transient and inconsistent with the subject*s clinical
•condition) may be repeated within the screening window to confirm abnormal
•results. If results return to protocol acceptable limits within the screening
•period, the subject may enter the study. Use local labs for CBC and use central
•labs for all other eligibility lab tests.
•2. Subjects who require phlebotomy at hematocrit levels lower than 45%.
•3. Pregnant or lactating females.
•4. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic
•vein thrombosis) within 2 months prior to randomization.
•5. Active or chronic bleeding within 2 months prior to randomization.
•6. Meets the criteria for post-polycythemia vera myelofibrosis as defined by
•the International Working Group-Myeloproliferative Neoplasms Research and
•Treatment (IWG-MRT).
•7. Any infection requiring systemic therapy within 1 month of dosing except
•controlled HIV, hepatitis B and hepatitis C. Prophylactic therapies are
•8. Any serious or unstable medical condition (e.g., poorly controlled HIV
•infection) or uncontrolled psychiatric condition as judged by the Investigator
•that would impair the subject*s ability to participate in the study.
•9. Major surgical procedure within 2 months prior to randomization unless the
•subject has fully recovered from surgery or planned major elective surgery
•during the study.
•10. History of invasive malignancies within the last 5 years, except
•a. localized cured cancer (e.g., prostate cancer and cervical cancer)
•b. localized cured in situ or stage 1 squamous cell carcinoma of the skin,
•basal cell carcinoma of the skin, or in situ melanoma of the skin.
•11. Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in
•situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the
•skin identified during the required dermatology examination at screening unless
•the cancer is adequately treated (i.e., treatment that is expected to be
•curative, such as Mohs surgery) before randomization. Note: Suspicious lesions
•should be biopsied and results available before randomization.
•12. Subjects with active alcohol or drug addiction that would interfere with
•their ability to comply with study requirements.
•13. Subjects who do not complete at least 4 days of Myelofibrosis Symptom
•Assessment Form version 4.0 (MFSAF v4.0) assessments within 1 week prior to
•randomization.
•14. Receipt of an investigational agent within 2 months or 5 half-lives,
•whichever is longer, prior to randomization.
•15. Received busulfan, pipobroman or Phosphorus within 7 months prior to
•16. Subjects with hypersensitivity to rusfertide or to any of the excipients or
•17. Subjects with any lesion or mass detected by physical examination or
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研究者

发起方

Protagonist Therapeutics, Inc.

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