A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

AMAG Pharmaceuticals, Inc.0 个研究点目标入组 75 人开始时间: 2019年3月27日最近更新: 2019年11月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AMAG Pharmaceuticals, Inc.
入组人数: 75

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 clinical trial of medicinal product

入排标准

入选标准

•1. Male or female 2 years to <18 years of age at time of consent
•2. Has IDA at Screening defined as:
•a) Hemoglobin (Hgb) <11.0 g/dL
•b) Any one or more of the following:
•Transferrin saturation (TSAT) <20%
•ferritin <100 ng/mL
•3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
•4. If sexually active and of childbearing potential (for both male and female subjects), be on an effective method of birth control for at least 1 month prior to Day 1 and agree to remain on birth control until completion of the study
•5. Subject and legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
•6. Subject and legal guardian has been informed of the investigational nature of this study; legal guardian has given voluntary written informed consent and, if appropriate, the subject has provided ‘assent’ in accordance with institutional, local, and national personal health data protection guidelines
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 75
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
•2. History of allergy to intravenous (IV) iron
•3. History of =2 clinically significant drug allergies
•4. Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
•5. Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
•6. Hgb =7.0 g/dL
•7. Serum ferritin level >600 ng/mL
•8. Parenteral iron therapy or blood transfusion within 4 weeks prior to Screening or planned for administration during the study
•9. ESA therapy within 4 weeks prior to Screening, or planned for administration during the study
•10. Known causes of anemia other than iron deficiency (e.g. vitamin B12 or folate deficiency, hemolytic anemia, etc.)
•11. Major surgery or invasive intervention within 4 weeks prior to Screening, or planned during the course of the study
•12. Active malignancy within 2 years prior to Screening (except non-melanoma skin cancer or carcinoma in situ that has been excised)
•13. Active clinically significant infection (e.g., systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening
•14. Received another investigational agent within 4 weeks prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study
•15. Female subjects who are pregnant or intend to become pregnant, are breastfeeding, are within 3 months postpartum, or have a positive pregnancy test
•16. Any other clinically significant condition or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s (and/or legal guardian’s) ability to adhere to the protocol, interfere with assessment of the investigational product, or serve as a contraindication to the subject’s
•participation in the study

研究者

发起方

AMAG Pharmaceuticals, Inc.

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