EUCTR2013-003877-87-CZ进行中（未招募）1 期
CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN(OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
Octapharma Pharmazeutika Prod.Ges.m.b.H0 个研究点目标入组 64 人开始时间: 2013年12月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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. Age of =2 years and =75 years.
- •2. Confirmed diagnosis of PI as defined by ESID and PAGID and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PI should be recorded.
- •3. Patients with at least 6 infusions on regular treatment with any IVIG, thereof a minimum of the last 2 months on the same product prior to entering the study. Constant IVIG dose between 200 and 800 mg/kg body weight (±20% of the mean dose for the last 6 infusions).
- •4. Availability of the IgG trough levels of 2 previous IVIG infusions before enrolment, and maintenance of =5.0 g/L in the trough levels of these 2 previous infusions.
- •5. Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
- •6. For adult patients: freely given written informed consent. For minor patients: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with the applicable regulatory requirements.
- •7. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
- •2. Known history of adverse reactions to IgA in other products.
- •3. Patients with body mass index =40 kg/m2.
- •4. Exposure to blood or any blood product or plasma derivatives, other than IVIG treatment for PID within the past 3 months prior to first infusion of octanorm.
- •5. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as polysorbate 80).
- •6. Requirement of any routine premedication for IgG administration.
- •7. History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
- •8. Severe liver function impairment (ALAT 3 times above upper limit of normal).
- •9. Known protein-losing enteropathies or proteinuria.
- •10. Presence of renal function impairment (creatinine >120 µM/L or creatinine >1,35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
- •11. Treatment with oral or parenteral steroids for =30 days or when given intermittently or as bolus at daily doses =0.15 mg/kg.
- •12. Treatment with immunosuppressive or immunomodulatory drugs.
- •13. Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
- •14. Treatment with any investigational medicinal product within 3 months prior to first infusion of octanorm.
- •15. Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
- •16. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
- •17. Known or suspected HIV, HCV, or HBV infection.
- •18. Pregnant or nursing women.
- •19. Planned pregnancy during course of the study.
研究者
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