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临床试验/NL-OMON54150
NL-OMON54150招募中2 期

A Phase 2, Open-label, Dose Escalation and Dose Expansion Study of KER-047 for the Treatment of IRIDA - IRIDA Study of KER-047

Keros Therapeutics, Inc.0 个研究点目标入组 1 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
招募中
入组人数
1
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

  • •Participants are eligible for the study if all of the following criteria apply:
  • •1. Male or female >= 18 years of age, at the time of signing informed consent.
  • •2. Confirmed diagnosis of IRIDA based on the following:
  • •- Documented homozygous or compound heterozygous TMPRSS6 gene variant(s) of
  • •Class 3 or greater (variant of uncertain significance, likely pathogenic,
  • •pathogenic) per the Association for Clinical Genomic Science.
  • •3. Serum TSAT at screening less than 15%.
  • •4. Participants receiving oral iron supplementation must be on a stable dose
  • •for >=4 weeks prior to Day 1, with a maximum of 60 mg/day of oral elemental
  • •iron. Intravenous (IV) iron is not permitted during the study.
  • •5. Ability to understand the purpose and risks of the study and provide signed
  • •and dated informed consent and authorization to use protected health
  • •information in accordance with national and local study participant privacy
  • •regulations.
  • •6. Females of childbearing potential and sexually active males must agree to
  • •use effective methods of contraception as outlined in the protocol.
  • •7. In the opinion of the Investigator, the participant is able and willing to
  • •comply with the requirements of the protocol (e.g., all study procedures,
  • •return for follow-up visits).

排除标准

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical History
  • •1. Body mass index >35 kg/m2
  • •2. Any active infection requiring parenteral antibiotic therapy within 28 days
  • •prior to Day 1 or oral antibiotics within 14 days of Day 1. Any infection with
  • •>5 days of fever (> 38.5* C) within 28 days prior to Day 1.
  • •3. Presence of uncontrolled heart disease or New York Heart Association Class 3
  • •or 4 heart failure.
  • •4. History or presence at screening of an uncontrolled chronic disease.
  • •5. History of drug or alcohol abuse, as defined by the investigator, within the
  • •past 2 years.
  • •6. History of stroke, arterial embolism, or unresolved deep venous thrombosis
  • •within 6 months prior to Day 1.
  • •7. Major surgery within 28 days prior to Day 1. Participants who had surgery
  • •more than 28 days prior to Day 1 must have recovered satisfactorily to
  • •participate in the study, in the opinion of the Investigator.
  • •8. Known positive for human immunodeficiency virus, active infectious hepatitis
  • •B, or active infectious hepatitis C.
  • •9. Any malignancy that has not been in remission and/or has required systemic
  • •therapy including radiation, chemotherapy, hormonal therapy, or surgery within
  • •the last year prior to Day 1.
  • •10. History of solid organ or hematological transplantation.
  • •11. Have had a fracture within 4 weeks of D1.
  • •12. History of severe allergic or anaphylactic reactions or hypersensitivity to
  • •recombinant proteins or excipients in the IMP.
  • •Treatment History
  • •13. Treatment with IV iron within 28 days prior to study entry.
  • •14. Receiving treatment with proton pump inhibitors (PPIs). Participants
  • •receiving PPIs who discontinue use at least 7 days prior to Day 1 are permitted
  • •15. Receiving and plan to continue any disallowed medications.
  • •16. Treatment with another investigational drug or device, or approved therapy
  • •for investigational use <= 28 days prior to Day 1, or, if the half-life of the
  • •previous product is known, within 5 times the half-life prior to Day 1,
  • •whichever is longer.
  • •Laboratory Exclusions
  • •17. Hemoglobin level >=13.8 g/dL (8.56 mmol/L) (males) or >=12.1 g/dL (7.51
  • •mmol/L) (females)
  • •18. Serum ferritin < 50 or > 500 µg/L
  • •19. Absolute lymphocyte count < 1.00 x 109/L
  • •20. Absolute neutrophil count < 1.50 x 109/L
  • •21. Estimated glomerular filtration rate by Chronic Kidney Disease-Epidemiology
  • •Collaboration creatinine equation < 45 mL/min/1.73 m2
  • •22. Alanine transaminase or aspartate transaminase > 2 x upper limit of normal
  • •Miscellaneous
  • •23. Pregnant or lactating females.
  • •24. Any other condition not specifically noted above that, in the judgment of
  • •the Investigator or Sponsor, would preclude the participant from participating
  • •in the study.
  • •25. Participants who are investigational site staff members directly involved
  • •in the conduct of the trial and their immediate family members, site staff
  • 另有 4 项未显示

研究者

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