EUCTR2009-017737-21-DE进行中（未招募）不适用
A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose (1,000 mg iron) in Improving Fatigue Symptoms in Iron-deficient Non-anaemic (IDNA) Women of Child Bearing Age
Vifor Pharma0 个研究点目标入组 288 人开始时间: 2010年3月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 288
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
- 性别
- Female
入选标准
- •1. Signed informed consent prior to study specific procedures.
- •2. Premenopausal, regularly menstruating women.
- •3. Age =18 years.
- •4. Body weight between 50 and 90 kg.
- •5. Haemoglobin =115 g/L.
- •6. Iron deficiency at screening defined as follows:
- •- S-ferritin level <50 ng/mL, AND, TfS <20%, OR,
- •- S-ferritin level <15 ng/mL.
- •7. Serum C-reactive protein:
- •- <5 mg/L if not on oral contraception, OR,
- •- <20 mg/L if use of oral contraception.
- •8. Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items
- •9. Negative pregnancy test (serum human chorionic gonadotropin (hCG) at
- •10. Normal levels of vitamin B12 and folic acid at screening.
- •11. Adequate contraception during the study period and for 1 month following
- •study completion.
- •12. Availability and willingness to complete all study visits and procedures per
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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. Haemoglobin level <115 g/L.
- •2. Haemoglobinopathy.
- •3. Haemochromatose.
- •4. Major depressive disorder based on Patient Health Questionnaire (PHQ-9)
- •(5 items with scores =2; one of which corresponds to question number 1 or
- •5. Any active or unstable concurrent medical condition (e.g., cancer, renal
- •dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine
- •aminotransferase (ALT) >3-fold upper limit), angina (Class IV).
- •6. Known human immunodeficiency virus/acquired immunodeficiency
- •syndrome, hepatitis B virus or hepatitis C virus infection.
- •7. Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory
- •bowel disease).
- •8. Documented history of clinically significant level of sleep apnoea defined
- •as 5 or more episodes per hour of any type of apnoea.
- •9. Intake of concurrent medications that could interfere with physical or
- •mental performance (e.g., antidepressive, antihistamines, narcotic or any
- •chemotherapeutic agents known to cause drowsiness).
- •10. Important recent weight loss (>10% within the past month).
- •11. Body weight <50 kg or >90 kg.
- •12. Thyroid dysfunction, thyroid stimulating hormone >4 µU/mL.
- •13. Intake of iron preparations 4 weeks prior to screening.
- •14. Use of gestagens e.g., Implanon® Mirena®, Depo-
- •Provera® for menstruation repression (see Section 7.7, Prohibited Therapy
- •or Concomitant Treatment, page 35).
- •15. Known hypersensitivity to FCM or to any other iron preparation.
- •16. Pregnancy (positive hCG test at screening) or breast feeding.
- •17. Participation in any other interventional trial within 4 weeks prior to
- •18. Inability to fully comprehend and/or perform study procedures or provide
- •written consent in the Investigator’s opinion.
- •19. Subject is not using adequate contraceptive precautions during the study
- •and for up to 1 month after the last dose of the study medication. A highly
- •effective method of birth control is defined as those which result in a low
- •failure rate (i.e., less than 1% per year) when used consistently and
- •correctly such as implants, injectables, combined oral contraceptives, some
- •intra-uterine devices, sexual abstinence or vasectomised partner.
- •20. Subject previously has entered this study.
- •21. Subject will not be available for follow-up assessments.
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