EUCTR2008-004340-37-SK进行中（未招募）1 期
An open label, multinational, multicenter study to evaluate the safety of HX575 recombinant human erythropoietin alfa
Hexal Biotech ForschungsGmbH0 个研究点目标入组 800 人开始时间: 2008年10月24日最近更新:
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
- 800
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. Subjects must give written informed consent before any assessment is performed. Consent to participate in one of the three previous studies (see below) is not sufficient.
- •2. Male and female subjects having participated in one of the following studies:
- •Post-authorization safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v. (Protocol number: 2006-66-INJ-14, EUDRACT number: 2007-005728-34)
- •Randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenicity of subcutaneous EPO HEXAL vs. ERYPO® in the treatment of anemia associated with chronic renal insufficiency in predialysis subjects (Protocol number: 2007-22-INJ-17 (HX02), EUDRACT number: 2007-001906-26)
- •An open label, single-arm, baseline-controlled, multicenter study to evaluate the efficacy, safety and immunogenicity of subcutaneous HX575 administered once a week (qw) and once every two weeks (q2w) in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis subjects (Protocol number: HX575-304, EUDRACT number: 2008-002696-27)
- •Treatment with any ESA other than the study drug is not permitted between the subject’s end of the previous study and enrollment into HX575-305. Thus the baseline visit of the HX575-305 study must be combined with the final visit of the previous study.
- •3. Subjects with controlled symptomatic anemia under s.c. or i.v. maintenance therapy with HX575 or a comparator in one of the above studies
- •4. HX575 is not commercially available for the subject’s specific indication or mode of application in the subject’s country
- •5. Continued ability to follow study instructions and high probability to appear to study visits
- •6. Compliant with s.c. self administration in previous study (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. Subjects no longer requiring ESA therapy
- •2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •3. Uncontrolled hypertension, defined as systolic blood pressure of > 160 mmHg and diastolic blood pressure measurement > 100 mmHg (average of two values with at least one day between measurements)
- •4. Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product
- •5. History of PRCA or aplastic anemia
- •6. History of anti-erythropoietin antibodies
- •7. Cannot receive adequate antithrombotic prophylaxis for any reason
- •8. Pregnant women or nursing mothers
- •9. Women of childbearing potential who do not agree to maintain effective birth control during the study treatment period
- •10. Hypersensitivity to the active substance or to any of the excipients
- •11. Subjects with any form of psychiatric disorder which may invalidate communication
- •12. Previous participation in this study
研究者
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