ISRCTN05425999已完成不适用
Clinical study to evaluate the efficacy, pharmacokinetics and safety of immunoglobulin intravenous (human) 10% (NewGam) in patients with primary immunodeficiency diseases
Octapharma AG (Switzerland)0 个研究点目标入组 50 人开始时间: 2009年11月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 2 years and less than or equal to 75 years, either sex
- •2. For minor patients, above a minimum weight based on the amount of blood required for testing: per individual, the trial-related blood loss (including any losses in the manoeuvre) should not exceed 3% of the total blood volume during a period of 4 weeks and should not exceed 1% at any single time (the total volume of blood is estimated at 80 ml/kg body weight)
- •3. Confirmed diagnosis of common variable immunodeficiency (CVID) or X-linked agammaglobulinaemia (XLA)
- •4. Previously treated with a commercial immune globulin intravenous (human) every 21 - 28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
- •5. Availability of the immunoglobulin G (IgG) trough levels of the two previous infusions before enrolment, and maintenance of at least 5.5 g/l in the trough levels of these two infusions
- •6. Negative result on a pregnancy test (human chorionic gonadotrophin [HCG]-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study
- •7. 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 approvals.
- •8. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study
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 immunoglobulin A (IgA) in other products
- •3. Exposure to blood or any blood product or derivative, other than commercially available intravenous immunoglobulin (IVIG), within the past 3 months prior to enrolment
- •4. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product
- •5. Requirement of any routine pre-medication for IVIG infusion
- •6. History of congenital impairment of pulmonary function
- •7. Severe liver function impairment (alanine aminotransferase [ALAT] 3 x upper limit of normal)
- •8. Presence of renal function impairment (creatinine greater than 120 µmol/L), or predisposition for acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs)
- •9. History of autoimmune haemolytic anaemia
- •10. History of diabetes mellitus
- •11. Congestive heart failure New York Heart Association (NYHA) class III or IV
- •12. Non-controlled arterial hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg)
- •13. History of deep vein thrombosis or thrombotic complications of IVIG therapy
- •14. A positive result at screening on any of the following viral markers: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV)
- •15. Presence of any clinically relevant disease or unstable condition at screening, other than PID, which in the opinion of the investigator could interfere with the conduct of the study
- •16. Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, greater than or equal to 0.15 mg of prednisone or equivalent/kg/day), immunosuppressive or immunomodulatory drugs
- •17. Planned vaccination during the study period
- •18. Treatment with any investigational agent within 3 months prior to enrolment
- •19. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrolment
- •20. Pregnant or nursing women
研究者
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