EUCTR2011-004561-33-AT进行中（未招募）1 期
A randomized, controlled, single-blinded, phase II study to investigate the safety and efficacy of intravenous infusions of FERINJECT® versus placebo on platelet activity in patients with iron deficiency and chronic inflammatory bowel disease. The ThromboAct trial - ThromboAct
Medizinische Universität Wien, Klinik für Innere Medizin III, Abteilung für Gastroenterologie und Hepatologie0 个研究点目标入组 40 人开始时间: 2014年5月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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.Male or female, inpatient or outpatient, aged at least 18 years and not more than 60 years.
- •2.Transferrin saturation (TfS) <16% or ferritin < 100?g/l
- •3.Previously diagnosed inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
- •4.Females of child-bearing potential must have a negative urine pregnancy test at screening and be practicing an acceptable method of birth control during the study and for up to 1month after the last dose of the study medication. Acceptable methods of birth control include barrier methods (including male and female condoms), diaphragms (cervical caps) with intravaginal spermicide (including jellies, foams and suppositories), intra-uterine devices or hormonal contraceptives. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or postmenopausal with no menstrual bleeding
- •5.Demonstrate the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to undergo the required assessments.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Harvey Bradshaw Index >7 (10) , Mayo Score >5 (11)
- •2.Significant anemia (hemoglobin <9 g/dl)
- •3.Bodyweight < 50kg
- •4.Blood transfusions or iron therapy during the previous 4 weeks, or erythropoietin treatment within the 8 weeks prior to enrolment.
- •5.Concomitant therapy with prednisolon above 20mg/d, 6-mercaptopurine, infliximab or azathioprine must have been initiated at least 4 months prior to study and the dose must be stable for at least 8 weeks. Other drugs with known effects on megakaryopoiesis (e.g. interferon-alpha).
- •6.Severe concomitant disease or need for surgery within 8 weeks
- •7.Hemochromatosis or other iron-storage disorders
- •8.Treatment with an investigational drug within the 30 days prior to enrolment
- •9.Active severe infection or malignancy other than carcinoma in situ of the cervix and non-melanoma skin cancer.
- •10.Bone Marrow Disease (MDS, thalassemia, etc)
- •11.Active or chronic liver or kidney disease. Serum albumin <25 g/L or serum creatinine >20 mg/L
- •12.Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator. Known hypersensitivity to FERINJECT®
- •13.Positive for HIV 1/HIV 2 antibodies (anti HIV) (HIV: human immunodeficiency virus).
- •14.Positive for hepatitis B surface-antigen (HBsAg), hepatitis C virus antibody (anti HCV) and evidence for active hepatitis, i.e., abnormal liver function test (LFT) results.
研究者
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