EUCTR2009-016727-53-DK进行中（未招募）1 期
A phase III, randomized, open-label study of intravenous iron isomaltoside 1000 (Monofer®) as mono therapy (without erythropoeisis stimulating agents) in comparison with oral iron sulfate in subjects with non-myeloid malignancies associated with Chemotherapy induced anaemia (CIA). - P-Monofer-CIA-01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- All
入选标准
- •1.Men and women, aged more than 18 years.
- •2.Subjects diagnosed with non-myeloid malignancies ( including all solid tumors,
- •Low Grade Lymphoma (LGL), Chronic Lymphatic Leukemia (CLL) and Myeloma)
- •receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles
- •3.Hb < 12 g/dL (7.4 mmol/L).
- •4.TfS <50%.
- •5.Serum Ferritin <800 ng/ml.
- •6.An Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •7.Willingness to participate after informed consent (including HIPAA, if
- •applicable).
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Anaemia caused primarily by other factors than CIA.
- •2.IV or oral iron treatment within 4 weeks prior to screening visit.
- •3.Erythrypoietin treatment within 4 weeks prior to screening visit.
- •4.Blood transfusion within 4 weeks prior to screening visit.
- •5.Imminent expectation of blood transfusion on part of treating physician.
- •6.Iron overload or disturbances in enrolment of iron (e.g. haemochromatosis
- •and haemosiderosis).
- •7.Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron
- •mono- or disaccharide complexes or to iron sulfate).
- •8.Known hypersensitivity to any excipients in the investigational drug
- •9.Subjects with a history of multiple allergies.
- •10.Decompensated liver cirrhosis and hepatitis (alanine aminotransferase
- •(ALAT) > 3 times upper normal limit).
- •11.History of Immunocompromise and/or history of Hepatitis B and/or C.
- •12.Active acute or chronic infections (assessed by clinical judgement and if
- •deemed necessary by investigator supplied with white blood cells (WBC)
- •and C-reactive protein (CRP)).
- •13.Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •14.Pregnancy and nursing (To avoid pregnancy, women have to be
- •postmenopausal (at least 12 months must have elapsed since last
- •menstruation), surgically sterile, or women of child bearing potential must
- •use one of the following contraceptives during the whole study period and
- •after the study has ended for at least 5 times plasma biological half-life of
- •the investigational medicinal product: Contraceptive pills, intrauterine
- •devices (IUD), contraceptive depot injections (prolonged-release
- •gestagen), subdermal implantation, vaginal ring, and transdermal
- •15.Planned elective surgery during the study.
- •16.Participation in any other clinical study (except chemotherapy protocol)
- •within 3 months prior to screening.
- •17.Known intolerance to oral iron treatment.
- •18.Untreated B12 or folate deficiency.
- •19.Any other medical condition that, in the opinion of Principal Investigator,
- •may cause the subject to be unsuitable for the completion of the study or
- •place the subject at potential risk from being in the study. Example,
- •Uncontrolled Hypertension, Unstable Ischemic Heart Disease or
- •Uncontrolled Diabetes Mellitus.
研究者
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