An open label, multinational, multicenter study to evaluate the safety of HX575 recombinant human erythropoietin alfa

Hexal AG0 个研究点目标入组 800 人开始时间: 2009年1月19日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•1. Subjects must give written informed consent before any assessment is performed. Consent to participate in the previous study HX575-304 (see below) is not sufficient.
•2. Male and female subjects having participated in the following study HX575-304:
•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. maintenance therapy with HX575
•4. HX575 is not commercially available for the subject’s specific indication 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
•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

•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-EPO 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

发起方